Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT00619957
Status:
COMPLETED
Last Update Posted:
2011-10-28
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 year double-blind treatment followed by 2 year open-label treatment.', 'description': 'Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Year 2', 'description': 'Placebo tablet once weekly Years 1 \\& 2', 'otherNumAtRisk': 93, 'otherNumAffected': 66, 'seriousNumAtRisk': 93, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Risedronate Year 2', 'description': 'Risedronate 35 mg tablet once weekly Years 1 \\& 2', 'otherNumAtRisk': 191, 'otherNumAffected': 134, 'seriousNumAtRisk': 191, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Placebo-Risedronate Year 4', 'description': 'Placebo once weekly Years 1 \\& 2 followed by risedronate 35 mg once weekly Years 3 \\& 4', 'otherNumAtRisk': 67, 'otherNumAffected': 46, 'seriousNumAtRisk': 67, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Risedronate Year 4', 'description': 'Risedronate 35 mg tablet once weekly Years 1 thru 4', 'otherNumAtRisk': 151, 'otherNumAffected': 97, 'seriousNumAtRisk': 151, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastritis Erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 5, 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{'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Prostate Examination Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thoracic Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Localized Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lung Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Malignant Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pancreatitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Post Laminectomy Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Prostate Examination Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Prostatic Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Renal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Retroperitoneal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Small Cell Lung Cancer, Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Sudden Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vitamin B12 Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '2.21'}, {'value': '5.75', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '6.50'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.53', 'ciLowerLimit': '3.46', 'ciUpperLimit': '5.60', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '1.87'}, {'value': '3.60', 'groupId': 'OG001', 'lowerLimit': '2.96', 'upperLimit': '4.24'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '1.66', 'ciUpperLimit': '3.47', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '2.34'}, {'value': '4.60', 'groupId': 'OG001', 'lowerLimit': '3.91', 'upperLimit': '5.29'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.18', 'ciLowerLimit': '2.19', 'ciUpperLimit': '4.16', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '2.41'}, {'value': '5.98', 'groupId': 'OG001', 'lowerLimit': '5.22', 'upperLimit': '6.73'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.57', 'ciLowerLimit': '3.49', 'ciUpperLimit': '5.66', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '1.31'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.58'}]}]}], 'analyses': [{'pValue': '0.1856', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.99', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.29'}, {'value': '1.38', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.80'}]}]}], 'analyses': [{'pValue': '0.0346', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.05', 'ciUpperLimit': '1.25', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.73'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1.26', 'upperLimit': '2.26'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.41', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000', 'lowerLimit': '-0.41', 'upperLimit': '0.89'}, {'value': '1.71', 'groupId': 'OG001', 'lowerLimit': '1.21', 'upperLimit': '2.20'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.17', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '-0.32', 'upperLimit': '1.27'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '1.58'}]}]}], 'analyses': [{'pValue': '0.2538', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '1.36', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '1.43'}, {'value': '1.49', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '2.10'}]}]}], 'analyses': [{'pValue': '0.0537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '1.74', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '-0.43', 'upperLimit': '1.27'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '2.29'}]}]}], 'analyses': [{'pValue': '0.0081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.32', 'ciUpperLimit': '2.15', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '1.35'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '2.21'}]}]}], 'analyses': [{'pValue': '0.0187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.94', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '1.38'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '1.78'}]}]}], 'analyses': [{'pValue': '0.1408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '1.34', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '1.59'}, {'value': '1.89', 'groupId': 'OG001', 'lowerLimit': '1.30', 'upperLimit': '2.48'}]}]}], 'analyses': [{'pValue': '0.0129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.92', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '-0.37', 'upperLimit': '1.41'}, {'value': '2.83', 'groupId': 'OG001', 'lowerLimit': '2.16', 'upperLimit': '3.49'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.31', 'ciLowerLimit': '1.35', 'ciUpperLimit': '3.26', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '-0.29', 'upperLimit': '1.44'}, {'value': '2.73', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '3.38'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.22', 'ciUpperLimit': '3.08', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.56', 'groupId': 'OG000', 'lowerLimit': '-21.87', 'upperLimit': '-7.26'}, {'value': '-58.16', 'groupId': 'OG001', 'lowerLimit': '-63.64', 'upperLimit': '-52.68'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.60', 'ciLowerLimit': '-51.52', 'ciUpperLimit': '-35.67', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 3', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in CTx, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.72', 'groupId': 'OG000', 'lowerLimit': '-25.91', 'upperLimit': '-1.52'}, {'value': '-58.44', 'groupId': 'OG001', 'lowerLimit': '-67.63', 'upperLimit': '-49.25'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.72', 'ciLowerLimit': '-58.01', 'ciUpperLimit': '-31.43', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in CTx, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.12', 'groupId': 'OG000', 'lowerLimit': '-31.66', 'upperLimit': '-6.58'}, {'value': '-61.46', 'groupId': 'OG001', 'lowerLimit': '-70.80', 'upperLimit': '-52.11'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.33', 'ciLowerLimit': '-55.99', 'ciUpperLimit': '-28.67', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled centers.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in CTx, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '9.28', 'groupId': 'OG000', 'lowerLimit': '-2.60', 'upperLimit': '21.16'}, {'value': '-37.27', 'groupId': 'OG001', 'lowerLimit': '-46.06', 'upperLimit': '-28.48'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.55', 'ciLowerLimit': '-59.38', 'ciUpperLimit': '-33.72', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '6.39', 'groupId': 'OG000', 'lowerLimit': '-4.55', 'upperLimit': '17.34'}, {'value': '-38.76', 'groupId': 'OG001', 'lowerLimit': '-46.97', 'upperLimit': '-30.54'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.15', 'ciLowerLimit': '-57.01', 'ciUpperLimit': '-33.29', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.41', 'groupId': 'OG000', 'lowerLimit': '-24.38', 'upperLimit': '-10.43'}, {'value': '-33.28', 'groupId': 'OG001', 'lowerLimit': '-38.58', 'upperLimit': '-27.98'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.88', 'ciLowerLimit': '-23.43', 'ciUpperLimit': '-8.32', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 3', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.98', 'groupId': 'OG000', 'lowerLimit': '-16.33', 'upperLimit': '0.38'}, {'value': '-29.97', 'groupId': 'OG001', 'lowerLimit': '-36.34', 'upperLimit': '-23.60'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.00', 'ciLowerLimit': '-31.08', 'ciUpperLimit': '-12.91', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.46', 'groupId': 'OG000', 'lowerLimit': '-24.55', 'upperLimit': '-8.37'}, {'value': '-38.42', 'groupId': 'OG001', 'lowerLimit': '-44.45', 'upperLimit': '-32.39'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.96', 'ciLowerLimit': '-30.75', 'ciUpperLimit': '-13.17', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.27', 'groupId': 'OG000', 'lowerLimit': '-30.69', 'upperLimit': '-13.85'}, {'value': '-37.38', 'groupId': 'OG001', 'lowerLimit': '-43.69', 'upperLimit': '-31.07'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.11', 'ciLowerLimit': '-24.20', 'ciUpperLimit': '-6.02', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.45', 'groupId': 'OG000', 'lowerLimit': '-28.68', 'upperLimit': '-12.23'}, {'value': '-36.82', 'groupId': 'OG001', 'lowerLimit': '-43.04', 'upperLimit': '-30.60'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.37', 'ciLowerLimit': '-25.24', 'ciUpperLimit': '-7.49', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.89', 'groupId': 'OG000', 'lowerLimit': '-12.25', 'upperLimit': '-5.53'}, {'value': '-24.53', 'groupId': 'OG001', 'lowerLimit': '-27.05', 'upperLimit': '-22.00'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.64', 'ciLowerLimit': '-19.29', 'ciUpperLimit': '-11.99', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 3', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in BAP, Month 6, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.68', 'groupId': 'OG000', 'lowerLimit': '-12.82', 'upperLimit': '-4.54'}, {'value': '-29.78', 'groupId': 'OG001', 'lowerLimit': '-32.90', 'upperLimit': '-26.66'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.10', 'ciLowerLimit': '-25.61', 'ciUpperLimit': '-16.59', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 6', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in BAP, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.11', 'groupId': 'OG000', 'lowerLimit': '-12.08', 'upperLimit': '-2.14'}, {'value': '-29.51', 'groupId': 'OG001', 'lowerLimit': '-33.21', 'upperLimit': '-25.81'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.39', 'ciLowerLimit': '-27.80', 'ciUpperLimit': '-16.98', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in BAP, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '-7.87', 'upperLimit': '13.77'}, {'value': '-25.20', 'groupId': 'OG001', 'lowerLimit': '-33.20', 'upperLimit': '-17.20'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.15', 'ciLowerLimit': '-39.84', 'ciUpperLimit': '-16.47', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '-7.60', 'upperLimit': '11.57'}, {'value': '-25.27', 'groupId': 'OG001', 'lowerLimit': '-32.46', 'upperLimit': '-18.07'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.25', 'ciLowerLimit': '-37.63', 'ciUpperLimit': '-16.87', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Height, Month 12, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-2.49', 'upperLimit': '0.94'}, {'value': '-0.92', 'groupId': 'OG001', 'lowerLimit': '-2.20', 'upperLimit': '0.37'}]}]}], 'analyses': [{'pValue': '0.8794', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-1.99', 'ciUpperLimit': '1.71', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 12', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Height, Month 24, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.66', 'groupId': 'OG000', 'lowerLimit': '-4.67', 'upperLimit': '-0.65'}, {'value': '-3.13', 'groupId': 'OG001', 'lowerLimit': '-4.62', 'upperLimit': '-1.64'}]}]}], 'analyses': [{'pValue': '0.6658', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-2.62', 'ciUpperLimit': '1.67', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Month 24', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.39', 'groupId': 'OG000', 'lowerLimit': '-4.34', 'upperLimit': '-0.44'}, {'value': '-2.68', 'groupId': 'OG001', 'lowerLimit': '-4.14', 'upperLimit': '-1.22'}]}]}], 'analyses': [{'pValue': '0.7840', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-2.39', 'ciUpperLimit': '1.81', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Fixed effects for treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'unitOfMeasure': 'millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population, LOCF (Last Observation Carried Forward)'}, {'type': 'SECONDARY', 'title': 'Percent of Responders Lumbar Spine BMD, Month 24, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Controlled for pooled center.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'responder = positive change (\\>0) in lumbar spine BMD from Baseline to Month 24', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Fractures, 12 Months, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciPctValue': '95', 'paramValue': '0.771', 'ciLowerLimit': '0.184', 'ciUpperLimit': '3.226', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 12', 'description': 'Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year', 'unitOfMeasure': 'Fractures / 100 patients / year', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Fractures, 24 Months, ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'OG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.688', 'ciLowerLimit': '0.245', 'ciUpperLimit': '1.932', 'groupDescription': 'A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years', 'unitOfMeasure': 'Fractures / 100 patients / 2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'FG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}], 'periods': [{'title': 'Month 24 Double-Blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'Intent to Treat (ITT Population)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'comment': 'One subject did not take any study medication.', 'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not take any study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Month 48 Open-Label', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Recruitment began on 03 Jun 2002.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years'}, {'id': 'BG001', 'title': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': 'Between 65 and <75 years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT Population', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Lebanon', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-20', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2011-05-23', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-20', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).'}, {'measure': 'Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).'}, {'measure': 'Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).'}, {'measure': 'Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).'}, {'measure': 'Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).'}, {'measure': 'Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).'}, {'measure': 'Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\\[lunar\\]) - 0.008'}, {'measure': 'Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.'}, {'measure': 'Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.'}, {'measure': 'Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.'}, {'measure': 'Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint', 'description': 'DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.'}, {'measure': 'Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.', 'timeFrame': 'Baseline to Month 3'}, {'measure': 'Percent Change From Baseline in CTx, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6'}, {'measure': 'Percent Change From Baseline in CTx, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Percent Change From Baseline in CTx, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24'}, {'measure': 'Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint'}, {'measure': 'Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.', 'timeFrame': 'Baseline to Month 3'}, {'measure': 'Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6'}, {'measure': 'Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24'}, {'measure': 'Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint'}, {'measure': 'Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.', 'timeFrame': 'Baseline to Month 3'}, {'measure': 'Percent Change From Baseline in BAP, Month 6, ITT Population.', 'timeFrame': 'Baseline to Month 6'}, {'measure': 'Percent Change From Baseline in BAP, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Percent Change From Baseline in BAP, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24'}, {'measure': 'Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint'}, {'measure': 'Change From Baseline in Body Height, Month 12, ITT Population.', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Change From Baseline in Body Height, Month 24, ITT Population.', 'timeFrame': 'Baseline to Month 24'}, {'measure': 'Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.', 'timeFrame': 'Baseline to 24 Months/Endpoint'}, {'measure': 'Percent of Responders Lumbar Spine BMD, Month 24, ITT Population', 'timeFrame': 'Baseline to Month 24', 'description': 'responder = positive change (\\>0) in lumbar spine BMD from Baseline to Month 24'}, {'measure': 'Cumulative Incidence of Fractures, 12 Months, ITT Population', 'timeFrame': 'Baseline to Month 12', 'description': 'Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year'}, {'measure': 'Cumulative Incidence of Fractures, 24 Months, ITT Population', 'timeFrame': 'Baseline to Month 24', 'description': 'Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Other Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '22750403', 'type': 'DERIVED', 'citation': 'Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented osteoporosis of the femoral neck and lumbar spine\n\nExclusion Criteria:\n\n* BMI greater than or equal to 35'}, 'identificationModule': {'nctId': 'NCT00619957', 'briefTitle': 'Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Warner Chilcott'}, 'officialTitle': 'Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study', 'orgStudyIdInfo': {'id': '2001092 and 2001092 OL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years', 'interventionNames': ['Drug: Placebo tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Risedronate', 'description': '35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years', 'interventionNames': ['Drug: Risedronate']}], 'interventions': [{'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'one placebo once a week for two years followed by one 35 mg risedronate once a week for two years', 'armGroupLabels': ['1']}, {'name': 'Risedronate', 'type': 'DRUG', 'description': 'one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years', 'armGroupLabels': ['Risedronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '80227', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '34996', 'city': 'Stuart', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'city': 'Concord', 'country': 'Australia', 'facility': 'Research Facility', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Heidelburg', 'country': 'Australia', 'facility': 'Research Facility'}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Facility', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Angers', 'country': 'France', 'facility': 'Research Facility', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Facility', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Research Site', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Dietrich Wenderoth, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Procter and Gamble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Warner Chilcott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}