Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-04-13 @ 9:31 PM
Study NCT ID:
NCT00541658
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2007-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068296', 'term': 'Risedronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gwulff@wcrx.com', 'phone': '973-442-3376', 'title': 'Grexan Wulff, Manager Regulatory Affairs', 'organization': 'Warner Chilcott'}, 'certainAgreement': {'otherDetails': 'The findings of the study may be published in a scientific journal or presented at a scientific meeting. Before submitting the results of the study for publication or presentation, the Investigator will allow the sponsor 30 days in which to review and comment on the manuscript.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.", 'eventGroups': [{'id': 'EG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)', 'otherNumAtRisk': 307, 'otherNumAffected': 243, 'seriousNumAtRisk': 307, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week', 'otherNumAtRisk': 307, 'otherNumAffected': 250, 'seriousNumAtRisk': 307, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week', 'otherNumAtRisk': 308, 'otherNumAffected': 264, 'seriousNumAtRisk': 308, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 37, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 38, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 39, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 36, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 31, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood Parathyroid Hormone Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cholethiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Colonic Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dermatitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diverticulum Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Drug Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 308, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 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Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.296', 'ciLowerLimit': '-0.869', 'ciUpperLimit': '0.277', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 weeks / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg IRBB', 'description': '5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years'}, {'id': 'OG001', 'title': '35 mg DRFB + DRBB', 'description': 'Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.069', 'groupId': 'OG000', 'lowerLimit': '2.664', 'upperLimit': '3.474'}, {'value': '3.334', 'groupId': 'OG001', 'lowerLimit': '3.046', 'upperLimit': '3.622'}]}]}], 'analyses': [{'pValue': '0.2955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.265', 'ciLowerLimit': '-0.763', 'ciUpperLimit': '0.232', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant used.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '269', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.685', 'groupId': 'OG000', 'lowerLimit': '2.305', 'upperLimit': '3.066'}, {'value': '2.816', 'groupId': 'OG001', 'lowerLimit': '2.429', 'upperLimit': '3.203'}, {'value': '2.529', 'groupId': 'OG002', 'lowerLimit': '2.148', 'upperLimit': '2.910'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.131', 'ciLowerLimit': '-0.674', 'ciUpperLimit': '0.412', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.156', 'ciLowerLimit': '-0.382', 'ciUpperLimit': '0.695', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '3.035', 'groupId': 'OG000', 'lowerLimit': '2.627', 'upperLimit': '3.443'}, {'value': '3.293', 'groupId': 'OG001', 'lowerLimit': '2.883', 'upperLimit': '3.702'}, {'value': '3.357', 'groupId': 'OG002', 'lowerLimit': '2.949', 'upperLimit': '3.766'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.258', 'ciLowerLimit': '-0.836', 'ciUpperLimit': '0.321', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.322', 'ciLowerLimit': '-0.900', 'ciUpperLimit': '0.256', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.352', 'groupId': 'OG000', 'lowerLimit': '3.829', 'upperLimit': '4.874'}, {'value': '5.506', 'groupId': 'OG001', 'lowerLimit': '4.971', 'upperLimit': '6.040'}, {'value': '5.396', 'groupId': 'OG002', 'lowerLimit': '4.865', 'upperLimit': '5.926'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.154', 'ciLowerLimit': '-1.903', 'ciUpperLimit': '-0.405', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.044', 'ciLowerLimit': '-1.789', 'ciUpperLimit': '-0.299', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.147', 'groupId': 'OG000', 'lowerLimit': '3.653', 'upperLimit': '4.640'}, {'value': '5.205', 'groupId': 'OG001', 'lowerLimit': '4.703', 'upperLimit': '5.707'}, {'value': '5.068', 'groupId': 'OG002', 'lowerLimit': '4.574', 'upperLimit': '5.562'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.059', 'ciLowerLimit': '-1.762', 'ciUpperLimit': '-0.355', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.922', 'ciLowerLimit': '-1.620', 'ciUpperLimit': '-0.223', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}, {'value': '86.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0524', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.16', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '0.1207', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000'}, {'value': '87.4', 'groupId': 'OG001'}, {'value': '86.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.15', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '0.1639', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.14', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 / Endpoint', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000'}, {'value': '89.2', 'groupId': 'OG001'}, {'value': '92.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0476', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.16', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.20', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '87.9', 'groupId': 'OG001'}, {'value': '90.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '0.0066', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.18', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 / Endpoint', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.613', 'groupId': 'OG000', 'lowerLimit': '1.354', 'upperLimit': '1.872'}, {'value': '1.748', 'groupId': 'OG001', 'lowerLimit': '1.486', 'upperLimit': '2.010'}, {'value': '1.685', 'groupId': 'OG002', 'lowerLimit': '1.426', 'upperLimit': '1.943'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.135', 'ciLowerLimit': '-0.504', 'ciUpperLimit': '0.234', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effect for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.072', 'ciLowerLimit': '-0.437', 'ciUpperLimit': '0.294', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effect for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.809', 'groupId': 'OG000', 'lowerLimit': '1.524', 'upperLimit': '2.093'}, {'value': '2.130', 'groupId': 'OG001', 'lowerLimit': '1.845', 'upperLimit': '2.415'}, {'value': '2.099', 'groupId': 'OG002', 'lowerLimit': '1.815', 'upperLimit': '2.383'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.321', 'ciLowerLimit': '-0.724', 'ciUpperLimit': '0.082', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.290', 'ciLowerLimit': '-0.692', 'ciUpperLimit': '0.112', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.785', 'groupId': 'OG000', 'lowerLimit': '1.508', 'upperLimit': '2.062'}, {'value': '2.073', 'groupId': 'OG001', 'lowerLimit': '1.793', 'upperLimit': '2.352'}, {'value': '2.075', 'groupId': 'OG002', 'lowerLimit': '1.799', 'upperLimit': '2.352'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.288', 'ciLowerLimit': '-0.682', 'ciUpperLimit': '0.106', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effect for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.290', 'ciLowerLimit': '-0.681', 'ciUpperLimit': '0.101', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.177', 'groupId': 'OG000', 'lowerLimit': '1.805', 'upperLimit': '2.549'}, {'value': '2.821', 'groupId': 'OG001', 'lowerLimit': '2.438', 'upperLimit': '3.204'}, {'value': '2.764', 'groupId': 'OG002', 'lowerLimit': '2.389', 'upperLimit': '3.140'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.644', 'ciLowerLimit': '-1.179', 'ciUpperLimit': '-0.110', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.587', 'ciLowerLimit': '-1.116', 'ciUpperLimit': '-0.059', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.028', 'groupId': 'OG000', 'lowerLimit': '1.671', 'upperLimit': '2.386'}, {'value': '2.551', 'groupId': 'OG001', 'lowerLimit': '2.190', 'upperLimit': '2.912'}, {'value': '2.496', 'groupId': 'OG002', 'lowerLimit': '2.139', 'upperLimit': '2.853'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.522', 'ciLowerLimit': '-1.030', 'ciUpperLimit': '-0.014', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.468', 'ciLowerLimit': '-0.973', 'ciUpperLimit': '0.037', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.120', 'groupId': 'OG000', 'lowerLimit': '0.792', 'upperLimit': '1.447'}, {'value': '1.385', 'groupId': 'OG001', 'lowerLimit': '1.053', 'upperLimit': '1.716'}, {'value': '1.246', 'groupId': 'OG002', 'lowerLimit': '0.920', 'upperLimit': '1.572'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.265', 'ciLowerLimit': '-0.731', 'ciUpperLimit': '0.201', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled centers and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.126', 'ciLowerLimit': '-0.588', 'ciUpperLimit': '0.336', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.155', 'groupId': 'OG000', 'lowerLimit': '0.814', 'upperLimit': '1.496'}, {'value': '1.482', 'groupId': 'OG001', 'lowerLimit': '1.140', 'upperLimit': '1.825'}, {'value': '1.717', 'groupId': 'OG002', 'lowerLimit': '1.376', 'upperLimit': '2.058'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.328', 'ciLowerLimit': '-0.811', 'ciUpperLimit': '0.156', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled centers and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.563', 'ciLowerLimit': '-1.045', 'ciUpperLimit': '-0.080', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center, anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.180', 'groupId': 'OG000', 'lowerLimit': '0.853', 'upperLimit': '1.507'}, {'value': '1.507', 'groupId': 'OG001', 'lowerLimit': '1.177', 'upperLimit': '1.838'}, {'value': '1.717', 'groupId': 'OG002', 'lowerLimit': '1.390', 'upperLimit': '2.044'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.327', 'ciLowerLimit': '-0.793', 'ciUpperLimit': '0.138', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.537', 'ciLowerLimit': '-1.000', 'ciUpperLimit': '-0.074', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. LOCF at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.530', 'groupId': 'OG000', 'lowerLimit': '1.105', 'upperLimit': '1.955'}, {'value': '2.108', 'groupId': 'OG001', 'lowerLimit': '1.670', 'upperLimit': '2.545'}, {'value': '2.328', 'groupId': 'OG002', 'lowerLimit': '1.899', 'upperLimit': '2.758'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.578', 'ciLowerLimit': '-1.189', 'ciUpperLimit': '0.032', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.799', 'ciLowerLimit': '-1.403', 'ciUpperLimit': '-0.194', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.431', 'groupId': 'OG000', 'lowerLimit': '1.028', 'upperLimit': '1.834'}, {'value': '1.986', 'groupId': 'OG001', 'lowerLimit': '1.579', 'upperLimit': '2.393'}, {'value': '2.047', 'groupId': 'OG002', 'lowerLimit': '1.644', 'upperLimit': '2.449'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.555', 'ciLowerLimit': '-1.128', 'ciUpperLimit': '0.018', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.616', 'ciLowerLimit': '-1.185', 'ciUpperLimit': '-0.046', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effect for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. LOCF at Week 104.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.900', 'groupId': 'OG000', 'lowerLimit': '1.470', 'upperLimit': '2.329'}, {'value': '2.148', 'groupId': 'OG001', 'lowerLimit': '1.713', 'upperLimit': '2.583'}, {'value': '2.164', 'groupId': 'OG002', 'lowerLimit': '1.736', 'upperLimit': '2.592'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.249', 'ciLowerLimit': '-0.860', 'ciUpperLimit': '0.363', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.265', 'ciLowerLimit': '-0.871', 'ciUpperLimit': '0.342', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effect for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.297', 'groupId': 'OG000', 'lowerLimit': '1.854', 'upperLimit': '2.740'}, {'value': '2.854', 'groupId': 'OG001', 'lowerLimit': '2.409', 'upperLimit': '3.299'}, {'value': '2.819', 'groupId': 'OG002', 'lowerLimit': '2.376', 'upperLimit': '3.262'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.557', 'ciLowerLimit': '-1.185', 'ciUpperLimit': '0.071', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.522', 'ciLowerLimit': '-1.149', 'ciUpperLimit': '0.105', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.186', 'groupId': 'OG000', 'lowerLimit': '1.746', 'upperLimit': '2.625'}, {'value': '2.732', 'groupId': 'OG001', 'lowerLimit': '2.288', 'upperLimit': '3.175'}, {'value': '2.764', 'groupId': 'OG002', 'lowerLimit': '2.326', 'upperLimit': '3.203'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.546', 'ciLowerLimit': '-1.170', 'ciUpperLimit': '0.078', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.579', 'ciLowerLimit': '-1.199', 'ciUpperLimit': '0.042', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '3.056', 'groupId': 'OG000', 'lowerLimit': '2.523', 'upperLimit': '3.589'}, {'value': '4.152', 'groupId': 'OG001', 'lowerLimit': '3.603', 'upperLimit': '4.700'}, {'value': '4.246', 'groupId': 'OG002', 'lowerLimit': '3.707', 'upperLimit': '4.785'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.095', 'ciLowerLimit': '-1.861', 'ciUpperLimit': '-0.329', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.190', 'ciLowerLimit': '-1.948', 'ciUpperLimit': '-0.432', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2.772', 'groupId': 'OG000', 'lowerLimit': '2.255', 'upperLimit': '3.289'}, {'value': '3.691', 'groupId': 'OG001', 'lowerLimit': '3.169', 'upperLimit': '4.213'}, {'value': '3.828', 'groupId': 'OG002', 'lowerLimit': '3.312', 'upperLimit': '4.344'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.919', 'ciLowerLimit': '-1.655', 'ciUpperLimit': '-0.184', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.056', 'ciLowerLimit': '-1.787', 'ciUpperLimit': '-0.326', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.595', 'groupId': 'OG000', 'lowerLimit': '-45.869', 'upperLimit': '-39.320'}, {'value': '-46.366', 'groupId': 'OG001', 'lowerLimit': '-49.673', 'upperLimit': '-43.059'}, {'value': '-45.420', 'groupId': 'OG002', 'lowerLimit': '-48.714', 'upperLimit': '-42.126'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.771', 'ciLowerLimit': '-0.885', 'ciUpperLimit': '8.427', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.826', 'ciLowerLimit': '-1.819', 'ciUpperLimit': '7.471', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 13', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.075', 'groupId': 'OG000', 'lowerLimit': '-46.449', 'upperLimit': '-39.702'}, {'value': '-45.705', 'groupId': 'OG001', 'lowerLimit': '-49.119', 'upperLimit': '-42.291'}, {'value': '-47.692', 'groupId': 'OG002', 'lowerLimit': '-51.062', 'upperLimit': '-44.323'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.630', 'ciLowerLimit': '-2.171', 'ciUpperLimit': '7.431', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.617', 'ciLowerLimit': '-0.152', 'ciUpperLimit': '9.386', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.223', 'groupId': 'OG000', 'lowerLimit': '-45.710', 'upperLimit': '-38.735'}, {'value': '-47.263', 'groupId': 'OG001', 'lowerLimit': '-50.771', 'upperLimit': '-43.754'}, {'value': '-46.863', 'groupId': 'OG002', 'lowerLimit': '-50.345', 'upperLimit': '-43.380'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.040', 'ciLowerLimit': '0.091', 'ciUpperLimit': '9.989', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.640', 'ciLowerLimit': '-0.293', 'ciUpperLimit': '9.574', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.227', 'groupId': 'OG000', 'lowerLimit': '-43.773', 'upperLimit': '-36.680'}, {'value': '-46.599', 'groupId': 'OG001', 'lowerLimit': '-50.180', 'upperLimit': '-43.017'}, {'value': '-44.630', 'groupId': 'OG002', 'lowerLimit': '-48.185', 'upperLimit': '-41.075'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.372', 'ciLowerLimit': '1.329', 'ciUpperLimit': '11.414', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.403', 'ciLowerLimit': '-0.619', 'ciUpperLimit': '9.425', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.188', 'groupId': 'OG000', 'lowerLimit': '-53.061', 'upperLimit': '-45.314'}, {'value': '-53.927', 'groupId': 'OG001', 'lowerLimit': '-57.870', 'upperLimit': '-49.983'}, {'value': '-53.186', 'groupId': 'OG002', 'lowerLimit': '-57.111', 'upperLimit': '-49.261'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.739', 'ciLowerLimit': '-0.793', 'ciUpperLimit': '10.271', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.999', 'ciLowerLimit': '-1.518', 'ciUpperLimit': '9.515', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.261', 'groupId': 'OG000', 'lowerLimit': '-50.137', 'upperLimit': '-42.386'}, {'value': '-51.079', 'groupId': 'OG001', 'lowerLimit': '-54.993', 'upperLimit': '-47.165'}, {'value': '-49.454', 'groupId': 'OG002', 'lowerLimit': '-53.338', 'upperLimit': '-45.569'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.817', 'ciLowerLimit': '-0.693', 'ciUpperLimit': '10.327', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.192', 'ciLowerLimit': '-2.295', 'ciUpperLimit': '8.680', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled centers and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.331', 'groupId': 'OG000', 'lowerLimit': '-45.643', 'upperLimit': '-39.019'}, {'value': '-46.781', 'groupId': 'OG001', 'lowerLimit': '-50.127', 'upperLimit': '-43.436'}, {'value': '-46.054', 'groupId': 'OG002', 'lowerLimit': '-49.386', 'upperLimit': '-42.723'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.450', 'ciLowerLimit': '-0.260', 'ciUpperLimit': '9.160', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.723', 'ciLowerLimit': '-0.975', 'ciUpperLimit': '8.421', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 13', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.386', 'groupId': 'OG000', 'lowerLimit': '-47.882', 'upperLimit': '-40.889'}, {'value': '-49.183', 'groupId': 'OG001', 'lowerLimit': '-52.743', 'upperLimit': '-45.623'}, {'value': '-49.358', 'groupId': 'OG002', 'lowerLimit': '-52.863', 'upperLimit': '-45.852'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.798', 'ciLowerLimit': '-0.195', 'ciUpperLimit': '9.790', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.972', 'ciLowerLimit': '0.020', 'ciUpperLimit': '9.924', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.410', 'groupId': 'OG000', 'lowerLimit': '-48.140', 'upperLimit': '-40.680'}, {'value': '-49.185', 'groupId': 'OG001', 'lowerLimit': '-52.931', 'upperLimit': '-45.440'}, {'value': '-50.048', 'groupId': 'OG002', 'lowerLimit': '-53.780', 'upperLimit': '-46.316'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.775', 'ciLowerLimit': '-0.514', 'ciUpperLimit': '10.065', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciPctValue': '95', 'paramValue': '5.638', 'ciLowerLimit': '0.356', 'ciUpperLimit': '10.920', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.172', 'groupId': 'OG000', 'lowerLimit': '-45.959', 'upperLimit': '-38.385'}, {'value': '-48.724', 'groupId': 'OG001', 'lowerLimit': '-52.556', 'upperLimit': '-44.892'}, {'value': '-47.703', 'groupId': 'OG002', 'lowerLimit': '-51.506', 'upperLimit': '-43.901'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.552', 'ciLowerLimit': '1.162', 'ciUpperLimit': '11.942', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.531', 'ciLowerLimit': '0.164', 'ciUpperLimit': '10.897', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.155', 'groupId': 'OG000', 'lowerLimit': '-48.803', 'upperLimit': '-39.506'}, {'value': '-51.985', 'groupId': 'OG001', 'lowerLimit': '-56.737', 'upperLimit': '-47.232'}, {'value': '-52.538', 'groupId': 'OG002', 'lowerLimit': '-57.257', 'upperLimit': '-47.818'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.830', 'ciLowerLimit': '1.175', 'ciUpperLimit': '14.485', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.383', 'ciLowerLimit': '1.757', 'ciUpperLimit': '15.010', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled centers and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.451', 'groupId': 'OG000', 'lowerLimit': '-45.960', 'upperLimit': '-36.942'}, {'value': '-49.253', 'groupId': 'OG001', 'lowerLimit': '-53.815', 'upperLimit': '-44.691'}, {'value': '-48.752', 'groupId': 'OG002', 'lowerLimit': '-53.279', 'upperLimit': '-44.224'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.802', 'ciLowerLimit': '1.385', 'ciUpperLimit': '14.220', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. 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Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. 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Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.805', 'ciLowerLimit': '-1.087', 'ciUpperLimit': '4.698', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 13', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.273', 'groupId': 'OG000', 'lowerLimit': '-33.311', 'upperLimit': '-29.236'}, {'value': '-33.680', 'groupId': 'OG001', 'lowerLimit': '-35.755', 'upperLimit': '-31.606'}, {'value': '-32.582', 'groupId': 'OG002', 'lowerLimit': '-34.625', 'upperLimit': '-30.540'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.407', 'ciLowerLimit': '-0.502', 'ciUpperLimit': '5.316', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.309', 'ciLowerLimit': '-1.576', 'ciUpperLimit': '4.194', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.895', 'groupId': 'OG000', 'lowerLimit': '-34.132', 'upperLimit': '-29.658'}, {'value': '-33.450', 'groupId': 'OG001', 'lowerLimit': '-35.696', 'upperLimit': '-31.204'}, {'value': '-33.507', 'groupId': 'OG002', 'lowerLimit': '-35.745', 'upperLimit': '-31.269'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.555', 'ciLowerLimit': '-1.617', 'ciUpperLimit': '4.727', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.612', 'ciLowerLimit': '-1.556', 'ciUpperLimit': '4.779', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.367', 'groupId': 'OG000', 'lowerLimit': '-33.536', 'upperLimit': '-29.199'}, {'value': '-32.802', 'groupId': 'OG001', 'lowerLimit': '-34.996', 'upperLimit': '-30.607'}, {'value': '-32.829', 'groupId': 'OG002', 'lowerLimit': '-35.007', 'upperLimit': '-30.652'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.434', 'ciLowerLimit': '-1.652', 'ciUpperLimit': '4.521', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.462', 'ciLowerLimit': '-1.611', 'ciUpperLimit': '4.535', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effect for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.394', 'groupId': 'OG000', 'lowerLimit': '-35.969', 'upperLimit': '-30.819'}, {'value': '-36.143', 'groupId': 'OG001', 'lowerLimit': '-38.776', 'upperLimit': '-33.510'}, {'value': '-36.810', 'groupId': 'OG002', 'lowerLimit': '-39.424', 'upperLimit': '-34.195'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.749', 'ciLowerLimit': '-0.938', 'ciUpperLimit': '6.436', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.416', 'ciLowerLimit': '-0.255', 'ciUpperLimit': '7.087', 'estimateComment': 'LS Mean Difference is 5 mg daily minus daily treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.572', 'groupId': 'OG000', 'lowerLimit': '-35.042', 'upperLimit': '-30.103'}, {'value': '-34.769', 'groupId': 'OG001', 'lowerLimit': '-37.268', 'upperLimit': '-32.271'}, {'value': '-34.824', 'groupId': 'OG002', 'lowerLimit': '-37.303', 'upperLimit': '-32.344'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.197', 'ciLowerLimit': '-1.318', 'ciUpperLimit': '5.711', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.251', 'ciLowerLimit': '-1.248', 'ciUpperLimit': '5.751', 'estimateComment': 'LS Mean Difference is 5 mg daily minus weekly treatment.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Fixed effects for treatment, pooled center and anticoagulant use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One New Fractured Vertebra, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.14', 'ciUpperLimit': '7.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.25', 'ciUpperLimit': '8.90', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.15', 'ciUpperLimit': '7.29', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.25', 'ciUpperLimit': '8.87', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.14', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.22', 'ciUpperLimit': '3.03', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.11', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '0.7719', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.37', 'ciUpperLimit': '3.90', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With No New Fractured Vertebra, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.14', 'ciUpperLimit': '7.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.25', 'ciUpperLimit': '8.90', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.15', 'ciUpperLimit': '7.29', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.25', 'ciUpperLimit': '8.87', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 / Endpoint', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 52.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With No New Fractured Vertebra, Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.14', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.22', 'ciUpperLimit': '3.03', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'OG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'OG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.11', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}, {'pValue': '0.7719', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.37', 'ciUpperLimit': '3.90', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104 / Endpoint', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Last Observation Carried Forward at Week 104.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'FG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'FG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '308'}, {'groupId': 'FG001', 'numSubjects': '307'}, {'groupId': 'FG002', 'numSubjects': '308'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '307'}, {'groupId': 'FG002', 'numSubjects': '308'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '234'}, {'groupId': 'FG002', 'numSubjects': '240'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'Took No Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '923 women with PMO at 43 sites in 8 countries across North America, South America, and the European Union. Patients were randomized within a site to 1 of 3 treatment groups (35 mg delayed-release Risedronate, given once-weekly before/after breakfast, and 5 mg immediate-release Risedronate, administered once-daily before breakfast) in a 1:1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}, {'value': '923', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '5 mg Before Breakfast', 'description': '5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)'}, {'id': 'BG001', 'title': '35 mg After Breakfast', 'description': '35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week'}, {'id': 'BG002', 'title': '35 mg Before Breakfast', 'description': '35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '66.0', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '65.7', 'spread': '7.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'ITT Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '401', 'groupId': 'BG003'}]}]}, {'title': 'Between 65 and < 75 years', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '402', 'groupId': 'BG003'}]}]}, {'title': '> = 75 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT Population', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}, {'value': '922', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT Population', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 923}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-15', 'studyFirstSubmitDate': '2007-10-05', 'resultsFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2007-10-05', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-23', 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population', 'timeFrame': '52 weeks / Endpoint'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population', 'timeFrame': 'Week 52', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.'}, {'measure': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.'}, {'measure': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population', 'timeFrame': 'Week 52', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.'}, {'measure': 'Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint', 'description': 'Responder = a patient showing a positive change (\\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.'}, {'measure': 'Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population', 'timeFrame': 'Week 13'}, {'measure': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population', 'timeFrame': 'Week 13'}, {'measure': 'Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population', 'timeFrame': 'Week 13'}, {'measure': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population', 'timeFrame': 'Week 26'}, {'measure': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Number of Patients With at Least One New Fractured Vertebra, Week 52', 'timeFrame': 'Week 52'}, {'measure': 'Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population', 'timeFrame': 'Week 104'}, {'measure': 'Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population', 'timeFrame': 'Week 104 / Endpoint'}, {'measure': 'Number of Patients With No New Fractured Vertebra, Week 52', 'timeFrame': 'Week 52'}, {'measure': 'Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint', 'timeFrame': 'Week 52 / Endpoint'}, {'measure': 'Number of Patients With No New Fractured Vertebra, Week 104', 'timeFrame': 'Week 104'}, {'measure': 'Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint', 'timeFrame': 'Week 104 / Endpoint'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '21947137', 'type': 'DERIVED', 'citation': 'McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL, Balske A, Burgio DE, Sarley J, McCullough LK, Recker RR. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporos Int. 2012 Jan;23(1):267-76. doi: 10.1007/s00198-011-1791-y. Epub 2011 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.', 'detailedDescription': 'The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female: 50 years of age or older\n* \\>5 years since last menses natural or surgical\n* have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture\n\nExclusion Criteria:\n\n* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia\n* BMI \\>32 kg/m\n* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone\n* hypocalcemia or hypercalcemia of any cause\n* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator'}, 'identificationModule': {'nctId': 'NCT00541658', 'briefTitle': 'A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Warner Chilcott'}, 'officialTitle': 'A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.', 'orgStudyIdInfo': {'id': '2007008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5 mg Before Breakfast', 'description': '5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)', 'interventionNames': ['Drug: risedronate']}, {'type': 'EXPERIMENTAL', 'label': '35 mg After Breakfast', 'description': '35 mg / Delayed-release Risedronate (Immediately Following Breakfast)', 'interventionNames': ['Drug: risedronate']}, {'type': 'EXPERIMENTAL', 'label': '35 mg Before Breakfast', 'description': '35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)', 'interventionNames': ['Drug: risedronate']}], 'interventions': [{'name': 'risedronate', 'type': 'DRUG', 'otherNames': ['IRBB'], 'description': '5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily', 'armGroupLabels': ['5 mg Before Breakfast']}, {'name': 'risedronate', 'type': 'DRUG', 'otherNames': ['DRFB'], 'description': '35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly', 'armGroupLabels': ['35 mg After Breakfast']}, {'name': 'risedronate', 'type': 'DRUG', 'otherNames': ['DRBB'], 'description': '35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly', 'armGroupLabels': ['35 mg Before Breakfast']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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