Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-02 @ 11:35 AM
Study NCT ID:
NCT00091832
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2004-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'D004164', 'term': 'Diphosphonates'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '25 weeks', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.', 'otherNumAtRisk': 43, 'otherNumAffected': 36, 'seriousNumAtRisk': 43, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)', 'otherNumAtRisk': 42, 'otherNumAffected': 33, 'seriousNumAtRisk': 42, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)', 'otherNumAtRisk': 41, 'otherNumAffected': 37, 'seriousNumAtRisk': 41, 'seriousNumAffected': 19}, {'id': 'EG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)', 'otherNumAtRisk': 43, 'otherNumAffected': 36, 'seriousNumAtRisk': 43, 'seriousNumAffected': 16}, {'id': 'EG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)', 'otherNumAtRisk': 42, 'otherNumAffected': 37, 'seriousNumAtRisk': 42, 'seriousNumAffected': 14}, {'id': 'EG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)', 'otherNumAtRisk': 43, 'otherNumAffected': 35, 'seriousNumAtRisk': 43, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 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'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary retention', 'stats': 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by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.52', 'spread': '74.16', 'groupId': 'OG000'}, {'value': '-53.46', 'spread': '100.77', 'groupId': 'OG001'}, {'value': '-43.16', 'spread': '101.08', 'groupId': 'OG002'}, {'value': '-59.41', 'spread': '43.31', 'groupId': 'OG003'}, {'value': '-41.79', 'spread': '72.61', 'groupId': 'OG004'}, {'value': '-39.96', 'spread': '65.85', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.848', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '0.68', 'ciUpperLimit': '4.35', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.51', 'ciUpperLimit': '3.24', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.34', 'ciUpperLimit': '2.29', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.51', 'ciUpperLimit': '3.20', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '0.70', 'ciUpperLimit': '4.34', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 13', 'description': 'The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. 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Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '86'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '57'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '43'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '42'}, {'value': '9', 'groupId': 'OG004', 'lowerLimit': '8', 'upperLimit': '29'}, {'value': '30', 'groupId': 'OG005', 'lowerLimit': '9', 'upperLimit': '141'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.31', 'estimateComment': 'A hazard ratio \\>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.65', 'estimateComment': 'A hazard ratio \\>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.74', 'estimateComment': 'A hazard ratio \\>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.74', 'estimateComment': 'A hazard ratio \\>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.83', 'estimateComment': 'A hazard ratio \\>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 57', 'description': 'Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.92', 'spread': '44.05', 'groupId': 'OG000'}, {'value': '-80.76', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '-78.45', 'spread': '28.89', 'groupId': 'OG002'}, {'value': '-81.79', 'spread': '13.29', 'groupId': 'OG003'}, {'value': '-70.50', 'spread': '41.76', 'groupId': 'OG004'}, {'value': '-78.13', 'spread': '16.66', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 13', 'description': 'Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-73.09', 'spread': '22.42', 'groupId': 'OG000'}, {'value': '-82.70', 'spread': '11.92', 'groupId': 'OG001'}, {'value': '-74.48', 'spread': '30.26', 'groupId': 'OG002'}, {'value': '-80.07', 'spread': '22.26', 'groupId': 'OG003'}, {'value': '-70.64', 'spread': '36.94', 'groupId': 'OG004'}, {'value': '-78.31', 'spread': '14.00', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.75', 'spread': '29.47', 'groupId': 'OG000'}, {'value': '-52.35', 'spread': '36.90', 'groupId': 'OG001'}, {'value': '-48.23', 'spread': '36.83', 'groupId': 'OG002'}, {'value': '-50.47', 'spread': '54.67', 'groupId': 'OG003'}, {'value': '-43.94', 'spread': '44.53', 'groupId': 'OG004'}, {'value': '-59.42', 'spread': '18.60', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). 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Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.01', 'spread': '24.42', 'groupId': 'OG000'}, {'value': '26.37', 'spread': '406.79', 'groupId': 'OG001'}, {'value': '-40.23', 'spread': '27.34', 'groupId': 'OG002'}, {'value': '-38.42', 'spread': '25.44', 'groupId': 'OG003'}, {'value': '-37.11', 'spread': '31.33', 'groupId': 'OG004'}, {'value': '-35.94', 'spread': '25.49', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.56', 'spread': '26.02', 'groupId': 'OG000'}, {'value': '15.88', 'spread': '347.47', 'groupId': 'OG001'}, {'value': '-49.01', 'spread': '21.24', 'groupId': 'OG002'}, {'value': '-52.60', 'spread': '16.23', 'groupId': 'OG003'}, {'value': '-46.72', 'spread': '23.25', 'groupId': 'OG004'}, {'value': '-48.24', 'spread': '27.61', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 13 in Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.82', 'spread': '49.78', 'groupId': 'OG000'}, {'value': '-19.35', 'spread': '38.71', 'groupId': 'OG001'}, {'value': '-2.39', 'spread': '47.96', 'groupId': 'OG002'}, {'value': '-6.23', 'spread': '40.82', 'groupId': 'OG003'}, {'value': '-23.78', 'spread': '35.46', 'groupId': 'OG004'}, {'value': '-5.96', 'spread': '41.92', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 25 in Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.74', 'spread': '86.98', 'groupId': 'OG000'}, {'value': '-30.78', 'spread': '34.94', 'groupId': 'OG001'}, {'value': '-22.80', 'spread': '46.36', 'groupId': 'OG002'}, {'value': '-26.95', 'spread': '41.49', 'groupId': 'OG003'}, {'value': '-23.93', 'spread': '43.99', 'groupId': 'OG004'}, {'value': '-22.69', 'spread': '36.79', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Time to First Skeletal Related Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median could not be calculated due to the low number of skeletal-related events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median could not be calculated due to the low number of skeletal-related events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median could not be calculated due to the low number of skeletal-related events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median could not be calculated due to the low number of skeletal-related events', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median could not be calculated due to the low number of skeletal-related events', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median could not be calculated due to the low number of skeletal-related events', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.543', 'ciLowerLimit': '0.159', 'ciUpperLimit': '1.856', 'estimateComment': 'A hazard ratio \\<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.544', 'ciLowerLimit': '0.159', 'ciUpperLimit': '1.859', 'estimateComment': 'A hazard ratio \\<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.791', 'ciLowerLimit': '0.266', 'ciUpperLimit': '2.355', 'estimateComment': 'A hazard ratio \\<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.073', 'ciLowerLimit': '0.389', 'ciUpperLimit': '2.963', 'estimateComment': 'A hazard ratio \\<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.540', 'ciLowerLimit': '0.158', 'ciUpperLimit': '1.847', 'estimateComment': 'A hazard ratio \\<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Week 25', 'description': 'Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were exposed to investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Skeletal Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '0.51', 'ciUpperLimit': '7.17', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.36', 'ciUpperLimit': '3.97', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.26', 'ciUpperLimit': '2.52', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.5', 'ciUpperLimit': '7.05', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.5', 'ciUpperLimit': '7.05', 'estimateComment': 'Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Week 25', 'description': 'Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were exposed to investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'OG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'OG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'OG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 57', 'description': 'Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)'}, {'id': 'FG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'FG002', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'FG003', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'FG004', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'FG005', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '43'}]}, {'type': 'Received Study Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Ineligibility Determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 8 September 2004 through 9 May 2005'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '255', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Bisphosphonate IV Q4W', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion'}, {'id': 'BG001', 'title': 'Denosumab 30 mg Q4W', 'description': 'Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'BG002', 'title': 'Denosumab 60 mg Q12W', 'description': 'Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'BG003', 'title': 'Denosumab 180 mg Q12W', 'description': 'Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)'}, {'id': 'BG004', 'title': 'Denosumab 120 mg Q4W', 'description': 'Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'BG005', 'title': 'Denosumab 180 mg Q4W', 'description': 'Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '58.2', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '57.4', 'spread': '11.0', 'groupId': 'BG004'}, {'value': '57.6', 'spread': '13.9', 'groupId': 'BG005'}, {'value': '57.8', 'spread': '11.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '255', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '179', 'groupId': 'BG006'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'uNTx/Cr', 'classes': [{'categories': [{'measurements': [{'value': '83.16', 'spread': '94.37', 'groupId': 'BG000'}, {'value': '66.44', 'spread': '61.17', 'groupId': 'BG001'}, {'value': '89.41', 'spread': '98.58', 'groupId': 'BG002'}, {'value': '75.92', 'spread': '91.03', 'groupId': 'BG003'}, {'value': '102.06', 'spread': '129.12', 'groupId': 'BG004'}, {'value': '98.22', 'spread': '168.42', 'groupId': 'BG005'}, {'value': '85.78', 'spread': '111.94', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Urinary N-telopeptide corrected by creatinine (uNTx/Cr)', 'unitOfMeasure': 'nmol/mmol', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum CTx', 'classes': [{'categories': [{'measurements': [{'value': '0.592', 'spread': '0.284', 'groupId': 'BG000'}, {'value': '0.632', 'spread': '0.430', 'groupId': 'BG001'}, {'value': '0.720', 'spread': '0.559', 'groupId': 'BG002'}, {'value': '0.647', 'spread': '0.703', 'groupId': 'BG003'}, {'value': '0.714', 'spread': '0.564', 'groupId': 'BG004'}, {'value': '0.846', 'spread': '0.892', 'groupId': 'BG005'}, {'value': '0.692', 'spread': '0.605', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Type I serum C-Telopeptide (CTx)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TRAP 5b', 'classes': [{'categories': [{'measurements': [{'value': '6.907', 'spread': '3.280', 'groupId': 'BG000'}, {'value': '6.879', 'spread': '2.878', 'groupId': 'BG001'}, {'value': '7.116', 'spread': '3.493', 'groupId': 'BG002'}, {'value': '7.628', 'spread': '6.830', 'groupId': 'BG003'}, {'value': '6.765', 'spread': '4.340', 'groupId': 'BG004'}, {'value': '7.009', 'spread': '4.217', 'groupId': 'BG005'}, {'value': '7.057', 'spread': '4.358', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Tartrate-resistant acid phosphatase 5b (TRAP 5b)', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BSAP', 'classes': [{'categories': [{'measurements': [{'value': '54.84', 'spread': '51.69', 'groupId': 'BG000'}, {'value': '44.33', 'spread': '26.06', 'groupId': 'BG001'}, {'value': '45.62', 'spread': '26.02', 'groupId': 'BG002'}, {'value': '62.39', 'spread': '109.18', 'groupId': 'BG003'}, {'value': '47.89', 'spread': '30.46', 'groupId': 'BG004'}, {'value': '48.82', 'spread': '35.13', 'groupId': 'BG005'}, {'value': '50.75', 'spread': '55.04', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Bone specific alkaline phosphatase (BSAP)', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'P1NP', 'classes': [{'categories': [{'measurements': [{'value': '111.01', 'spread': '97.21', 'groupId': 'BG000'}, {'value': '98.54', 'spread': '72.69', 'groupId': 'BG001'}, {'value': '114.29', 'spread': '113.51', 'groupId': 'BG002'}, {'value': '193.03', 'spread': '641.13', 'groupId': 'BG003'}, {'value': '98.47', 'spread': '83.46', 'groupId': 'BG004'}, {'value': '139.01', 'spread': '188.02', 'groupId': 'BG005'}, {'value': '126.20', 'spread': '284.81', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Procollagen 1 N-terminal peptide (P1NP)', 'unitOfMeasure': 'µg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Osleocalcin', 'classes': [{'categories': [{'measurements': [{'value': '9.42', 'spread': '5.89', 'groupId': 'BG000'}, {'value': '9.25', 'spread': '4.98', 'groupId': 'BG001'}, {'value': '10.04', 'spread': '5.70', 'groupId': 'BG002'}, {'value': '8.96', 'spread': '5.03', 'groupId': 'BG003'}, {'value': '8.09', 'spread': '3.36', 'groupId': 'BG004'}, {'value': '9.31', 'spread': '4.06', 'groupId': 'BG005'}, {'value': '9.20', 'spread': '4.93', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'dispFirstSubmitDate': '2009-11-23', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2004-09-17', 'dispFirstSubmitQcDate': '2009-11-23', 'resultsFirstSubmitDate': '2010-12-09', 'studyFirstSubmitQcDate': '2004-09-20', 'dispFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-09', 'studyFirstPostDateStruct': {'date': '2004-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13', 'timeFrame': 'Baseline and Week 13', 'description': 'The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.'}, {'measure': 'Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.'}, {'measure': 'Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline', 'timeFrame': 'Baseline to Week 57', 'description': 'Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.'}, {'measure': 'Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)', 'timeFrame': 'Baseline and week 13', 'description': 'Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 25 in P1NP', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.'}, {'measure': 'Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Percent Change From Baseline to Week 13 in Osteocalcin', 'timeFrame': 'Baseline and Week 13', 'description': 'Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.'}, {'measure': 'Percent Change From Baseline to Week 25 in Osteocalcin', 'timeFrame': 'Baseline and Week 25', 'description': 'Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.'}, {'measure': 'Time to First Skeletal Related Event', 'timeFrame': 'Day 1 to Week 25', 'description': 'Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).'}, {'measure': 'Number of Participants With Skeletal Related Events', 'timeFrame': 'From Day 1 to Week 25', 'description': 'Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).'}, {'measure': 'Number of Participants With Hypercalcemia', 'timeFrame': 'Day 1 to Week 57', 'description': 'Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.'}]}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Cancer'], 'conditions': ['Breast Cancer', 'Metastases', 'Bone Metastases in Subjects With Advanced Breast Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Campbell-Baird C, Lipton A, Sarkenshik M, Ma H, Jun S.Incidence of Acute Phase Events Following Denosumab or Intravenous Bisphosphonates: Results From a Randomized, Controlled Phase 2 Study in Patients With Breast Cancer and Bone Metastases.Journal-001752;2010;7:85-89.'}, {'pmid': '18927312', 'type': 'BACKGROUND', 'citation': 'Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res. 2008 Oct 15;14(20):6690-6. doi: 10.1158/1078-0432.CCR-07-5234.'}, {'pmid': '17785705', 'type': 'BACKGROUND', 'citation': 'Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman R, Paterson AH, Peterson MC, Fan M, Kinsey A, Jun S. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases. J Clin Oncol. 2007 Oct 1;25(28):4431-7. doi: 10.1200/JCO.2007.11.8604. Epub 2007 Sep 4.'}, {'type': 'BACKGROUND', 'citation': 'Peterson M, Rodriquez R., Gurrola E., Sohn W, Jun S (others??).Population pharmacokinetics and pharmacodynamics of denosumab in breast cancer patients with bone metastases.Journal-000709;'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma\n\n* At least one bone metastasis'}, 'identificationModule': {'nctId': 'NCT00091832', 'briefTitle': 'Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.', 'orgStudyIdInfo': {'id': '20040113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denosumab 60 mg every 12 weeks', 'description': 'Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.', 'interventionNames': ['Biological: Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Denosumab 120 mg every 4 weeks', 'description': 'Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.', 'interventionNames': ['Biological: Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Denosumab 180 mg every 4 weeks', 'description': 'Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.', 'interventionNames': ['Biological: Denosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV bisphosphonates every 4 weeks', 'description': 'Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.', 'interventionNames': ['Drug: IV Bisphosphonates']}, {'type': 'EXPERIMENTAL', 'label': 'Denosumab 180 mg every 12 weeks', 'description': 'Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.', 'interventionNames': ['Biological: Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Denosumab 30 mg every 4 weeks', 'description': 'Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.', 'interventionNames': ['Biological: Denosumab']}], 'interventions': [{'name': 'Denosumab', 'type': 'BIOLOGICAL', 'otherNames': ['AMG 162'], 'description': 'Denosumab administered by subcutaneous injection', 'armGroupLabels': ['Denosumab 120 mg every 4 weeks', 'Denosumab 180 mg every 12 weeks', 'Denosumab 180 mg every 4 weeks', 'Denosumab 30 mg every 4 weeks', 'Denosumab 60 mg every 12 weeks']}, {'name': 'IV Bisphosphonates', 'type': 'DRUG', 'description': 'Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid', 'armGroupLabels': ['IV bisphosphonates every 4 weeks']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}