Viewing Study NCT00577720

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Ignite Creation Date: 2025-12-25 @ 4:29 AM
Ignite Modification Date: 2026-01-17 @ 3:10 AM
Study NCT ID: NCT00577720
Status: COMPLETED
Last Update Posted: 2012-01-13
First Post: 2007-12-19
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068296', 'term': 'Risedronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gwulff@wcrx.com', 'phone': '973-442-3376', 'title': 'Grexan Wulff, Manager Regulatory Affairs', 'organization': 'Warner Chilcott'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 Jul 2006 thru 27 Jan 2007', 'eventGroups': [{'id': 'EG000', 'title': '35 mg IRBB (Immediate Release Before Breakfast)', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks', 'otherNumAtRisk': 37, 'otherNumAffected': 27, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '35 mg DRFB (Delayed Release Following Breakfast)', 'description': '35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks', 'otherNumAtRisk': 36, 'otherNumAffected': 19, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '50 mg DRFB', 'description': '50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks', 'otherNumAtRisk': 36, 'otherNumAffected': 24, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '50 mg DRBB (Delayed Release Before Breakfast)', 'description': '50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks', 'otherNumAtRisk': 72, 'otherNumAffected': 51, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pain in Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Groin Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Stomach Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 26, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gingival Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fungal Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Blood Sodium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Blood Triglycerides Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 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{'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '35 mg IRBB (Immediate Release Before Breakfast)', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}, {'id': 'OG001', 'title': '35 mg DRFB (Delayed Release Following Breakfast)', 'description': '35 mg delayed release 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If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/50 mg DRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.068', 'ciLowerLimit': '0.867', 'ciUpperLimit': '1.321', 'groupDescription': 'For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/50 mg DRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.018', 'ciLowerLimit': '0.824', 'ciUpperLimit': '1.267', 'groupDescription': 'For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 13', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '35 mg IRBB (Immediate Release Before Breakfast)', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}, {'id': 'OG001', 'title': '35 mg DRFB (Delayed Release Following Breakfast)', 'description': '35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'OG002', 'title': '50 mg DRFB', 'description': '50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'OG003', 'title': '50 mg DRBB (Delayed Release Before Breakfast)', 'description': '50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.57', 'groupId': 'OG000', 'lowerLimit': '-56.60', 'upperLimit': '-20.54'}, {'value': '-46.60', 'groupId': 'OG001', 'lowerLimit': '-63.04', 'upperLimit': '-30.17'}, {'value': '-43.65', 'groupId': 'OG002', 'lowerLimit': '-61.62', 'upperLimit': '-25.67'}, {'value': '-54.27', 'groupId': 'OG003', 'lowerLimit': '-70.14', 'upperLimit': '-38.40'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (LS Mean 35 mg DRFB/35 mg IRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.208', 'ciLowerLimit': '0.749', 'ciUpperLimit': '2.099', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio (LS Mean 50 mg DRBB/35 mg IRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.132', 'ciLowerLimit': '0.665', 'ciUpperLimit': '2.003', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/35 mg IRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.407', 'ciLowerLimit': '0.913', 'ciUpperLimit': '2.404', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/35 mg DRFB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.165', 'ciLowerLimit': '0.797', 'ciUpperLimit': '1.752', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/50 mg DRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.243', 'ciLowerLimit': '0.828', 'ciUpperLimit': '1.990', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 13', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '35 mg IRBB (Immediate Release Before Breakfast)', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}, {'id': 'OG001', 'title': '35 mg DRFB (Delayed Release Following Breakfast)', 'description': '35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'OG002', 'title': '50 mg DRFB', 'description': '50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'OG003', 'title': '50 mg DRBB (Delayed Release Before Breakfast)', 'description': '50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.99', 'groupId': 'OG000', 'lowerLimit': '-19.62', 'upperLimit': '-2.365'}, {'value': '-10.41', 'groupId': 'OG001', 'lowerLimit': '-18.28', 'upperLimit': '-2.545'}, {'value': '-20.00', 'groupId': 'OG002', 'lowerLimit': '-28.60', 'upperLimit': '-11.40'}, {'value': '-17.36', 'groupId': 'OG003', 'lowerLimit': '-24.96', 'upperLimit': '-9.767'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (LS Mean 35 mg DRFB/35 mg IRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.947', 'ciLowerLimit': '0.316', 'ciUpperLimit': '2.993', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio (LS Mean 50 mg DRBB/35 mg IRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.820', 'ciLowerLimit': '0.929', 'ciUpperLimit': '5.429', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/35 mg IRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.580', 'ciLowerLimit': '0.801', 'ciUpperLimit': '4.718', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/35 mg DRFB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.668', 'ciLowerLimit': '0.856', 'ciUpperLimit': '4.668', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio (LS Mean 50 mg DRFB/50 mgDRBB)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.868', 'ciLowerLimit': '0.504', 'ciUpperLimit': '1.488', 'groupDescription': 'The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 13', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '35 mg IRBB (Immediate Release Before Breakfast)', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}, {'id': 'FG001', 'title': '35 mg DRFB (Delayed Release Following Breakfast)', 'description': '35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'FG002', 'title': '50 mg DRFB', 'description': '50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'FG003', 'title': '50 mg DRBB (Delayed Release Before Breakfast)', 'description': '50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'ITT (Intent to Treat) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Screening began 14-Jul-2006'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '35 mg IRBB (Immediate Release Before Breakfast)', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}, {'id': 'BG001', 'title': '35 mg DRFB (Delayed Release Following Breakfast)', 'description': '35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'BG002', 'title': '50 mg DRFB', 'description': '50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks'}, {'id': 'BG003', 'title': '50 mg DRBB (Delayed Release Before Breakfast)', 'description': '50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '6.1', 'groupId': 'BG002'}, {'value': '59.7', 'spread': '7.8', 'groupId': 'BG003'}, {'value': '59.9', 'spread': '7.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '181', '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'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', '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'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (Oriental)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2011-08-12', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-06', 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population', 'timeFrame': 'Baseline and Week 13'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population', 'timeFrame': 'Baseline and Week 13'}, {'measure': 'Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population', 'timeFrame': 'Baseline and Week 13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postmenopausal Women']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.', 'detailedDescription': 'To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In generally good health, as determined by medical history, physical examination, and laboratory test results\n* Postmenopausal greater than 2 years, naturally or surgically based on medical history.\n\nExclusion Criteria:\n\n* Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:\n\n * oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)\n * anabolic steroids\n * estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs\n * progestins\n * calcitonin\n * vitamin D supplements\n * calcitriol, calcidiol, or alfacalcidol at any dose\n * any bisphosphonate\n * fluoride\n * strontium\n * parathyroid hormone, including teriparatide'}, 'identificationModule': {'nctId': 'NCT00577720', 'briefTitle': 'Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Warner Chilcott'}, 'officialTitle': 'Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women', 'orgStudyIdInfo': {'id': '2005107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '35 mg IRBB', 'description': '35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks', 'interventionNames': ['Drug: risedronate']}, {'type': 'EXPERIMENTAL', 'label': '35 mg DRFB', 'description': '35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks', 'interventionNames': ['Drug: risedronate']}, {'type': 'EXPERIMENTAL', 'label': '50 mg DRFB', 'description': '50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks', 'interventionNames': ['Drug: risedronate']}, {'type': 'EXPERIMENTAL', 'label': '50 mg DRBB', 'description': '50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks', 'interventionNames': ['Drug: risedronate']}], 'interventions': [{'name': 'risedronate', 'type': 'DRUG', 'description': '35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks', 'armGroupLabels': ['35 mg IRBB']}, {'name': 'risedronate', 'type': 'DRUG', 'description': '35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks', 'armGroupLabels': ['35 mg DRFB']}, {'name': 'risedronate', 'type': 'DRUG', 'description': '50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks', 'armGroupLabels': ['50 mg DRFB']}, {'name': 'risedronate', 'type': 'DRUG', 'description': '50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks', 'armGroupLabels': ['50 mg DRBB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '32608', 'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Facility'}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '86813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Lu A Sun, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Procter and Gamble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Warner Chilcott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}