Viewing Study NCT00048061

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Ignite Creation Date: 2025-12-24 @ 12:56 PM
Ignite Modification Date: 2025-12-28 @ 12:33 PM
Study NCT ID: NCT00048061
Status: COMPLETED
Last Update Posted: 2018-03-29
First Post: 2002-10-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077557', 'term': 'Ibandronic Acid'}, {'id': 'D002118', 'term': 'Calcium'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '+41 616878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.', 'eventGroups': [{'id': 'EG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.', 'otherNumAtRisk': 395, 'otherNumAffected': 190, 'seriousNumAtRisk': 395, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.', 'otherNumAtRisk': 396, 'otherNumAffected': 190, 'seriousNumAtRisk': 396, 'seriousNumAffected': 54}, {'id': 'EG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.', 'otherNumAtRisk': 396, 'otherNumAffected': 191, 'seriousNumAtRisk': 396, 'seriousNumAffected': 55}, {'id': 'EG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.', 'otherNumAtRisk': 396, 'otherNumAffected': 182, 'seriousNumAtRisk': 396, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Localised osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 41}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Lower respiratory tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dacryocystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Ear infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Hematoma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Laryngopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Superinfection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Superinfection lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 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'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 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'Hyperparathyroidism primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 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'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7427', 'spread': '4.0149', 'groupId': 'OG000'}, {'value': '4.3395', 'spread': '3.9557', 'groupId': 'OG001'}, {'value': '4.0328', 'spread': '3.6815', 'groupId': 'OG002'}, {'value': '4.7611', 'spread': '3.8931', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.615', 'ciLowerLimit': '0.013', 'ciUpperLimit': '1.216', 'estimateComment': 'Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.'}, {'pValue': '0.338', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.297', 'ciLowerLimit': '-0.312', 'ciUpperLimit': '0.906', 'estimateComment': 'Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '0.395', 'ciUpperLimit': '1.605', 'estimateComment': 'Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Month 12', 'description': 'Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}, {'value': '291', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9623', 'spread': '4.6525', 'groupId': 'OG000'}, {'value': '5.3350', 'spread': '4.8235', 'groupId': 'OG001'}, {'value': '5.5760', 'spread': '4.2280', 'groupId': 'OG002'}, {'value': '6.5503', 'spread': '4.5118', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Month 24', 'description': 'Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At 12 months, n = 314, 322, 306, 314', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.0291', 'groupId': 'OG000'}, {'value': '0.033', 'spread': '0.0298', 'groupId': 'OG001'}, {'value': '0.030', 'spread': '0.0271', 'groupId': 'OG002'}, {'value': '0.036', 'spread': '0.0290', 'groupId': 'OG003'}]}]}, {'title': 'At 24 months, n = 294, 294, 278, 291', 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.0337', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '0.0355', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.0313', 'groupId': 'OG002'}, {'value': '0.049', 'spread': '0.0330', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'The absolute change (g/cm\\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '316', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'Total hip At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '1.9626', 'spread': '2.8311', 'groupId': 'OG000'}, {'value': '2.2172', 'spread': '2.7504', 'groupId': 'OG001'}, {'value': '2.6878', 'spread': '2.6646', 'groupId': 'OG002'}, {'value': '3.0092', 'spread': '2.7105', 'groupId': 'OG003'}]}]}, {'title': 'Total hip At Month 24, n = 292,291,277,289', 'categories': [{'measurements': [{'value': '2.4955', 'spread': '3.0884', 'groupId': 'OG000'}, {'value': '2.8132', 'spread': '3.2408', 'groupId': 'OG001'}, {'value': '3.5165', 'spread': '3.2831', 'groupId': 'OG002'}, {'value': '4.1601', 'spread': '2.8335', 'groupId': 'OG003'}]}]}, {'title': 'Trochanter At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '3.1917', 'spread': '4.1268', 'groupId': 'OG000'}, {'value': '3.4931', 'spread': '4.0876', 'groupId': 'OG001'}, {'value': '3.8226', 'spread': '3.7077', 'groupId': 'OG002'}, {'value': '4.5904', 'spread': '3.9436', 'groupId': 'OG003'}]}]}, {'title': 'Trochanter At Month 24, n = 292,291,277,289', 'categories': [{'measurements': [{'value': '4.0204', 'spread': '4.3460', 'groupId': 'OG000'}, {'value': '4.6289', 'spread': '4.5518', 'groupId': 'OG001'}, {'value': '5.3135', 'spread': '4.7335', 'groupId': 'OG002'}, {'value': '6.1755', 'spread': '4.2550', 'groupId': 'OG003'}]}]}, {'title': 'Femoral neck At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '1.7164', 'spread': '3.6233', 'groupId': 'OG000'}, {'value': '1.8141', 'spread': '3.4391', 'groupId': 'OG001'}, {'value': '1.8797', 'spread': '3.4998', 'groupId': 'OG002'}, {'value': '2.1914', 'spread': '3.4842', 'groupId': 'OG003'}]}]}, {'title': 'Femoral neck At Month 24, n=292,291,277,289', 'categories': [{'measurements': [{'value': '1.9087', 'spread': '4.2212', 'groupId': 'OG000'}, {'value': '2.0581', 'spread': '4.1189', 'groupId': 'OG001'}, {'value': '2.6209', 'spread': '3.8339', 'groupId': 'OG002'}, {'value': '3.1195', 'spread': '4.0549', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '316', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'Total hip At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.0204', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.0205', 'groupId': 'OG001'}, {'value': '0.020', 'spread': '0.0190', 'groupId': 'OG002'}, {'value': '0.022', 'spread': '0.0190', 'groupId': 'OG003'}]}]}, {'title': 'Total hip At Month 24, n = 292,291,277,290', 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.0225', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.0241', 'groupId': 'OG001'}, {'value': '0.026', 'spread': '0.0237', 'groupId': 'OG002'}, {'value': '0.031', 'spread': '0.0199', 'groupId': 'OG003'}]}]}, {'title': 'Trochanter At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.0228', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.0238', 'groupId': 'OG001'}, {'value': '0.022', 'spread': '0.0206', 'groupId': 'OG002'}, {'value': '0.026', 'spread': '0.0211', 'groupId': 'OG003'}]}]}, {'title': 'Trochanter At Month 24, n = 292,291,277,290', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.0241', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.0259', 'groupId': 'OG001'}, {'value': '0.030', 'spread': '0.0263', 'groupId': 'OG002'}, {'value': '0.035', 'spread': '0.0231', 'groupId': 'OG003'}]}]}, {'title': 'Femoral neck At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.0230', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.0226', 'groupId': 'OG001'}, {'value': '0.012', 'spread': '0.0228', 'groupId': 'OG002'}, {'value': '0.014', 'spread': '0.0224', 'groupId': 'OG003'}]}]}, {'title': 'Femoral neck At Month 24, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0265', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.0272', 'groupId': 'OG001'}, {'value': '0.017', 'spread': '0.0248', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.0257', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 314,322,306,314', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}, {'value': '87.6', 'groupId': 'OG001'}, {'value': '86.6', 'groupId': 'OG002'}, {'value': '90.8', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 294,294,278,291', 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}, {'value': '87.8', 'groupId': 'OG002'}, {'value': '93.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '306', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 315,319,306,306', 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000'}, {'value': '81.2', 'groupId': 'OG001'}, {'value': '86.9', 'groupId': 'OG002'}, {'value': '90.5', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 292,291,277,289', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000'}, {'value': '83.2', 'groupId': 'OG001'}, {'value': '88.8', 'groupId': 'OG002'}, {'value': '93.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '316', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '83.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}, {'value': '92.4', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 292,291,277,289', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}, {'value': '86.6', 'groupId': 'OG001'}, {'value': '89.9', 'groupId': 'OG002'}, {'value': '94.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '316', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 315,319,306,316', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}, {'value': '69.0', 'groupId': 'OG002'}, {'value': '75.3', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 292,291,277,289', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '78.7', 'groupId': 'OG002'}, {'value': '81.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 314,318,304,310', 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}, {'value': '77.6', 'groupId': 'OG002'}, {'value': '83.5', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 292,291,276,287', 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000'}, {'value': '75.3', 'groupId': 'OG001'}, {'value': '79.3', 'groupId': 'OG002'}, {'value': '87.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 314,318,304,310', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '75.5', 'groupId': 'OG001'}, {'value': '78.0', 'groupId': 'OG002'}, {'value': '84.2', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 292,291,276,287', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000'}, {'value': '77.3', 'groupId': 'OG001'}, {'value': '80.1', 'groupId': 'OG002'}, {'value': '88.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '310', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 12, n = 314,318,304,310', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}, {'value': '60.9', 'groupId': 'OG002'}, {'value': '68.7', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 292,291,276,287', 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}, {'value': '63.9', 'groupId': 'OG001'}, {'value': '71.0', 'groupId': 'OG002'}, {'value': '75.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '278', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'At Month 3, n = 269,278,271,276', 'categories': [{'measurements': [{'value': '-49.5458', 'spread': '30.8286', 'groupId': 'OG000'}, {'value': '-46.4771', 'spread': '26.5096', 'groupId': 'OG001'}, {'value': '-50.2368', 'spread': '28.1576', 'groupId': 'OG002'}, {'value': '-57.3433', 'spread': '33.9505', 'groupId': 'OG003'}]}]}, {'title': 'At Month 6, n = 270,272,274,278', 'categories': [{'measurements': [{'value': '55.5900', 'spread': '34.1672', 'groupId': 'OG000'}, {'value': '-53.9838', 'spread': '27.3557', 'groupId': 'OG001'}, {'value': '-55.9614', 'spread': '31.2801', 'groupId': 'OG002'}, {'value': '-66.4354', 'spread': '25.4762', 'groupId': 'OG003'}]}]}, {'title': 'At Month 12, n = 272,276,276,267', 'categories': [{'measurements': [{'value': '-58.8244', 'spread': '29.8250', 'groupId': 'OG000'}, {'value': '-57.5363', 'spread': '27.2271', 'groupId': 'OG001'}, {'value': '-58.1046', 'spread': '33.5095', 'groupId': 'OG002'}, {'value': '-67.0703', 'spread': '41.4563', 'groupId': 'OG003'}]}]}, {'title': 'At Month 24, n = 221,215,211,235', 'categories': [{'measurements': [{'value': '-51.2360', 'spread': '37.9032', 'groupId': 'OG000'}, {'value': '-51.3040', 'spread': '27.9844', 'groupId': 'OG001'}, {'value': '-49.5567', 'spread': '44.9707', 'groupId': 'OG002'}, {'value': '61.8822', 'spread': '28.2309', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Months 3, 6, 12, 24', 'description': 'Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Absolute Change In Baseline in Serum CTX to Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '267', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'Month 12, n = 272, 276, 276, 267', 'categories': [{'measurements': [{'value': '-0.323', 'spread': '0.2292', 'groupId': 'OG000'}, {'value': '-0.326', 'spread': '0.2212', 'groupId': 'OG001'}, {'value': '-0.340', 'spread': '0.2287', 'groupId': 'OG002'}, {'value': '-0.377', 'spread': '0.2135', 'groupId': 'OG003'}]}]}, {'title': 'Month 24, n = 221, 215, 211, 235', 'categories': [{'measurements': [{'value': '-0.285', 'spread': '0.2052', 'groupId': 'OG000'}, {'value': '-0.298', 'spread': '0.1980', 'groupId': 'OG001'}, {'value': '-0.312', 'spread': '0.2398', 'groupId': 'OG002'}, {'value': '-0.340', 'spread': '0.2062', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Events and Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}, {'value': '396', 'groupId': 'OG002'}, {'value': '396', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}, {'value': '317', 'groupId': 'OG003'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 24', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.'}, {'type': 'SECONDARY', 'title': 'Number Of Participants With Marked Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'OG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'classes': [{'title': 'Hematocrit Low, n = 389,387,382,385', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin High, n = 389,389,382,385', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin Low, n = 389,389,382,385', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'WBC Low, n = 389,389,382,385', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'ALT (SGPT) High, n = 390,390,385,385', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'BUN High, n = 390,390,385,385', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine High, n = 390,390,385,385', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Chloride Low, n =3 89,390,385,384', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Potassium Low, n = 389,390,385,383', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Sodium High, n = 389,390,385,384', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Sodium Low, n = 389,390,385,384', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Calcium High, n = 390,390,385,385', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Phosphate High, n = 390,390,385,385', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Phosphate Low, n = 390,390,385,385', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 24', 'description': 'Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \\[g/L\\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \\[mmol/L\\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \\[umol/L\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.'}, {'id': 'FG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'FG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'FG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '400'}, {'groupId': 'FG001', 'numSubjects': '401'}, {'groupId': 'FG002', 'numSubjects': '400'}, {'groupId': 'FG003', 'numSubjects': '401'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}, {'groupId': 'FG001', 'numSubjects': '328'}, {'groupId': 'FG002', 'numSubjects': '316'}, {'groupId': 'FG003', 'numSubjects': '322'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '79'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'Did not follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Early improvement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world.', 'preAssignmentDetails': 'A total of 1609 participants were randomized, of which 1602 received the study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}, {'value': '396', 'groupId': 'BG003'}, {'value': '1583', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibandronate 2.5 mg', 'description': 'Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'BG001', 'title': 'Ibandronate 50/50 mg', 'description': 'Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'BG002', 'title': 'Ibandronate 100 mg', 'description': 'Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'BG003', 'title': 'Ibandronate 150 mg', 'description': 'Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '6.61', 'groupId': 'BG000'}, {'value': '66.0', 'spread': '6.71', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '6.38', 'groupId': 'BG002'}, {'value': '66.2', 'spread': '6.64', 'groupId': 'BG003'}, {'value': '66.0', 'spread': '6.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}, {'value': '396', 'groupId': 'BG003'}, {'value': '1583', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1609}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2002-10-24', 'resultsFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2002-10-24', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-22', 'studyFirstPostDateStruct': {'date': '2002-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density', 'timeFrame': 'From Baseline (Month 0) to Month 12', 'description': 'Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.'}], 'secondaryOutcomes': [{'measure': 'Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD', 'timeFrame': 'From Baseline (Month 0) to Month 24', 'description': 'Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.'}, {'measure': 'Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'The absolute change (g/cm\\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.'}, {'measure': 'Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.'}, {'measure': 'Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center'}, {'measure': 'Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.'}, {'measure': 'Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.'}, {'measure': 'Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.'}, {'measure': 'Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.'}, {'measure': 'Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.'}, {'measure': 'Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.'}, {'measure': 'Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24', 'timeFrame': 'Months 12 and 24', 'description': 'A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.'}, {'measure': 'Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24', 'timeFrame': 'From Baseline (Month 0) to Months 3, 6, 12, 24', 'description': 'Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).'}, {'measure': 'Absolute Change In Baseline in Serum CTX to Months 12 and 24', 'timeFrame': 'From Baseline (Month 0) to Months 12 and 24', 'description': 'Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).'}, {'measure': 'Number of Participants With Any Adverse Events and Serious Adverse Event', 'timeFrame': 'Up to Month 24', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.'}, {'measure': 'Number Of Participants With Marked Laboratory Abnormalities', 'timeFrame': 'Up to Month 24', 'description': 'Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \\[g/L\\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \\[mmol/L\\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \\[umol/L\\].'}]}, 'conditionsModule': {'conditions': ['Post Menopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women 55-80 years of age;\n* post-menopausal for \\>= 5 years;\n* ambulatory.\n\nExclusion Criteria:\n\n* malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);\n* breast cancer within the previous 20 years;\n* allergy to bisphosphonates;\n* previous treatment with an intravenous bisphosphonate at any time;\n* previous treatment with an oral bisphosphonate within the last 6 months, \\>1 month of treatment within the last year, or \\>3 months of treatment within the last 2 years.'}, 'identificationModule': {'nctId': 'NCT00048061', 'briefTitle': 'MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis', 'orgStudyIdInfo': {'id': 'BM16549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ibandronate 2.5 mg', 'description': 'Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .', 'interventionNames': ['Drug: Ibandronate [Bonviva/Boniva]', 'Dietary Supplement: Calcium', 'Dietary Supplement: Vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Ibandronate 50/50 mg', 'description': 'Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.', 'interventionNames': ['Drug: Ibandronate [Bonviva/Boniva]', 'Dietary Supplement: Calcium', 'Dietary Supplement: Vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Ibandronate 100 mg', 'description': 'Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day', 'interventionNames': ['Drug: Ibandronate [Bonviva/Boniva]', 'Dietary Supplement: Calcium', 'Dietary Supplement: Vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Ibandronate 150 mg', 'description': 'Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day', 'interventionNames': ['Drug: Ibandronate [Bonviva/Boniva]', 'Dietary Supplement: Calcium', 'Dietary Supplement: Vitamin D']}], 'interventions': [{'name': 'Ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '2.5mg po daily', 'armGroupLabels': ['Ibandronate 2.5 mg']}, {'name': 'Ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '100mg po monthly on a single day', 'armGroupLabels': ['Ibandronate 50/50 mg']}, {'name': 'Ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '100mg po monthly over 2 consecutive days', 'armGroupLabels': ['Ibandronate 100 mg']}, {'name': 'Ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '150mg po monthly', 'armGroupLabels': ['Ibandronate 150 mg']}, {'name': 'Calcium', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg/day', 'armGroupLabels': ['Ibandronate 100 mg', 'Ibandronate 150 mg', 'Ibandronate 2.5 mg', 'Ibandronate 50/50 mg']}, {'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': '400 IU/day', 'armGroupLabels': ['Ibandronate 100 mg', 'Ibandronate 150 mg', 'Ibandronate 2.5 mg', 'Ibandronate 50/50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90211', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '80227', 'city': 'Lakewood', 'state': 'Colorado', 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