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Ignite Creation Date: 2025-12-25 @ 2:25 AM

Ignite Modification Date: 2026-02-25 @ 10:04 PM

Study NCT ID: NCT01575834

Status: COMPLETED

Last Update Posted: 2024-08-28

First Post: 2012-04-04

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hong Kong']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557282', 'term': 'romosozumab'}, {'id': 'D000069448', 'term': 'Denosumab'}], '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'}]}}, '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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Double-blind treatment period: 12 months; Overall study: 36 months', 'description': 'Six participants randomized to placebo received a dose of romosozumab in error during the double-blind period. Therefore, these 6 participants were included in the romosozumab group (ie, as treated) for safety analyses.\n\nOther Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': '12-Month Double-blind Period: Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months', 'otherNumAtRisk': 3576, 'otherNumAffected': 2059, 'seriousNumAtRisk': 3576, 'seriousNumAffected': 314}, {'id': 'EG001', 'title': '12-Month Double-blind Period: Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.', 'otherNumAtRisk': 3581, 'otherNumAffected': 2019, 'seriousNumAtRisk': 3581, 'seriousNumAffected': 344}, {'id': 'EG002', 'title': '36-Month Study Period: Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.', 'otherNumAtRisk': 3576, 'otherNumAffected': 2434, 'seriousNumAtRisk': 3576, 'seriousNumAffected': 733}, {'id': 'EG003', 'title': '36-Month Study Period: Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.', 'otherNumAtRisk': 3581, 'otherNumAffected': 2463, 'seriousNumAtRisk': 3581, 'seriousNumAffected': 728}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 138}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 210}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 189}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 191}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 182}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 180}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 169}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 240}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 237}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 439}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 460}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 622}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 651}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 161}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 255}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 236}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 263}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 244}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 206}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 263}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 230}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 102}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 204}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 179}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 319}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 255}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 539}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 484}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 434}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 468}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 663}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 668}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 380}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 373}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 573}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 518}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 163}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 201}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 211}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 168}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 260}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 263}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 184}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 329}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 321}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 299}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 278}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 407}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 417}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 154}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 216}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 228}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 206}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 235}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 270}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 293}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 179}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 189}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 219}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 411}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 384}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypocoagulable state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pernicious anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aortic valve disease mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Benign pleural neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Benign soft tissue neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bladder transitional cell carcinoma', 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3581, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 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'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3576, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3581, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3576, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3581, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With New Vertebral Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3322', 'groupId': 'OG000'}, {'value': '3321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.47', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Values \\< 1 for odds ratio favor romosozumab.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.\n\nThe Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:\n\n* Grade 0 (Normal) = no fracture;\n* Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);\n* Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;\n* Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 12 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With New Vertebral Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3327', 'groupId': 'OG000'}, {'value': '3325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.39', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Values \\< 1 for odds ratio favor romosozumab.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.'}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.\n\nThe Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:\n\n* Grade 0 (Normal) = no fracture;\n* Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);\n* Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;\n* Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clinical Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.89', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; Last observation carried forward imputation (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Nonvertebral Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.05', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Nonvertebral Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.97', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clinical Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.87', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Major Nonvertebral Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.02', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Major Nonvertebral Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.91', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3322', 'groupId': 'OG000'}, {'value': '3321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.49', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Values \\< 1 for odds ratio favor romosozumab.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3327', 'groupId': 'OG000'}, {'value': '3325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.41', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Values \\< 1 for odds ratio favor romosozumab.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Hip Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.35', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Hip Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.04', 'pValueComment': 'A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Major Osteoporotic Fracture Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.90', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Major Osteoporotic Fracture Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'OG000'}, {'value': '3589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.84', 'estimateComment': 'Hazard ratio \\< 1 favors romosozumab.', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3322', 'groupId': 'OG000'}, {'value': '3321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.87', 'estimateComment': 'Values \\< 1 for odds ratio favor romosozumab.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.'}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3327', 'groupId': 'OG000'}, {'value': '3325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.44', 'estimateComment': 'Values \\< 1 for odds ratio favor romosozumab.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.'}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3148', 'groupId': 'OG000'}, {'value': '3151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '12.4', 'ciUpperLimit': '12.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'groupDescription': 'The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2877', 'groupId': 'OG000'}, {'value': '2861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '10.8', 'ciUpperLimit': '11.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'groupDescription': 'The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 24', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3210', 'groupId': 'OG000'}, {'value': '3197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '5.6', 'ciUpperLimit': '6.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'groupDescription': 'The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2918', 'groupId': 'OG000'}, {'value': '2903', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '5.1', 'ciUpperLimit': '5.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'groupDescription': 'The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 24', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3210', 'groupId': 'OG000'}, {'value': '3197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '4.9', 'ciUpperLimit': '5.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'groupDescription': 'The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2918', 'groupId': 'OG000'}, {'value': '2903', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'OG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '4.7', 'ciUpperLimit': '5.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'groupDescription': 'The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 24', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'FG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3591'}, {'groupId': 'FG001', 'numSubjects': '3589'}]}, {'type': 'Received Double-blind Treatment', 'achievements': [{'comment': 'Six participants received a dose of romosozumab in error during the double-blind period.', 'groupId': 'FG000', 'numSubjects': '3582'}, {'groupId': 'FG001', 'numSubjects': '3575'}]}, {'type': 'Completed Double-blind Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3205'}, {'groupId': 'FG001', 'numSubjects': '3185'}]}, {'type': 'Completed 24-month Study Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3032'}, {'groupId': 'FG001', 'numSubjects': '2994'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 36-month study period', 'groupId': 'FG000', 'numSubjects': '2892'}, {'comment': 'Completed 36-month study period', 'groupId': 'FG001', 'numSubjects': '2851'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '699'}, {'groupId': 'FG001', 'numSubjects': '738'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '390'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Administrative decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Ineligibility Determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Requirement for Alternative Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This study was conducted at 222 centers in Europe, Central/Latin America, Asia, North America, and Australia/New Zealand.\n\nThe first participant enrolled on 15 March 2012 and the last participant enrolled on 06 December 2013.', 'preAssignmentDetails': 'Participants were randomized 1:1 to receive either romosozumab 210 mg or matched placebo for the 12-month, double-blind, placebo-controlled period. Randomization was stratified by age (\\< 75 years, ≥ 75 years) and prevalent vertebral fracture (yes, no), as determined by site staff at randomization based on local reading of the spine X-ray.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3591', 'groupId': 'BG000'}, {'value': '3589', 'groupId': 'BG001'}, {'value': '7180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Denosumab', 'description': 'Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'BG001', 'title': 'Romosozumab/Denosumab', 'description': 'Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '70.9', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '70.9', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 65 years', 'measurements': [{'value': '757', 'groupId': 'BG000'}, {'value': '768', 'groupId': 'BG001'}, {'value': '1525', 'groupId': 'BG002'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '2834', 'groupId': 'BG000'}, {'value': '2821', 'groupId': 'BG001'}, {'value': '5655', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3591', 'groupId': 'BG000'}, {'value': '3589', 'groupId': 'BG001'}, {'value': '7180', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1416', 'groupId': 'BG000'}, {'value': '1427', 'groupId': 'BG001'}, {'value': '2843', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2175', 'groupId': 'BG000'}, {'value': '2162', 'groupId': 'BG001'}, {'value': '4337', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '2052', 'groupId': 'BG000'}, {'value': '2063', 'groupId': 'BG001'}, {'value': '4115', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '441', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '866', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'American Indian/Alaska Native', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '901', 'groupId': 'BG000'}, {'value': '900', 'groupId': 'BG001'}, {'value': '1801', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prevalent Vertebral Fracture Strata per Randomization', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '3386', 'groupId': 'BG000'}, {'value': '3385', 'groupId': 'BG001'}, {'value': '6771', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Strata per randomization for prevalent fracture were based on local reading of baseline spine radiographs.', 'unitOfMeasure': 'Participants'}, {'title': 'Age Strata per Randomization', 'classes': [{'categories': [{'title': '< 75 years', 'measurements': [{'value': '2471', 'groupId': 'BG000'}, {'value': '2470', 'groupId': 'BG001'}, {'value': '4941', 'groupId': 'BG002'}]}, {'title': '≥ 75 years', 'measurements': [{'value': '1120', 'groupId': 'BG000'}, {'value': '1119', 'groupId': 'BG001'}, {'value': '2239', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set consisted of all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'dispFirstSubmitDate': '2016-03-07', 'completionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2012-04-04', 'dispFirstSubmitQcDate': '2016-03-07', 'resultsFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2012-04-10', 'dispFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-11', 'studyFirstPostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With New Vertebral Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.\n\nThe Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:\n\n* Grade 0 (Normal) = no fracture;\n* Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);\n* Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;\n* Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.'}, {'measure': 'Percentage of Participants With New Vertebral Fracture Through Month 24', 'timeFrame': '24 months', 'description': 'New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.\n\nThe Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:\n\n* Grade 0 (Normal) = no fracture;\n* Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);\n* Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;\n* Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Clinical Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.'}, {'measure': 'Percentage of Participants With a Nonvertebral Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.'}, {'measure': 'Percentage of Participants With a Nonvertebral Fracture Through Month 24', 'timeFrame': '24 Months', 'description': 'A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.'}, {'measure': 'Percentage of Participants With a Clinical Fracture Through Month 24', 'timeFrame': '24 Months', 'description': 'Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.'}, {'measure': 'Percentage of Participants With a Major Nonvertebral Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.'}, {'measure': 'Percentage of Participants With a Major Nonvertebral Fracture Through Month 24', 'timeFrame': '24 Months', 'description': 'A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.'}, {'measure': 'Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.'}, {'measure': 'Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24', 'timeFrame': '24 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.'}, {'measure': 'Percentage of Participants With a Hip Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.'}, {'measure': 'Percentage of Participants With a Hip Fracture Through Month 24', 'timeFrame': '24 Months', 'description': 'Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.'}, {'measure': 'Percentage of Participants With a Major Osteoporotic Fracture Through Month 12', 'timeFrame': '12 Months', 'description': 'Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.'}, {'measure': 'Percentage of Participants With a Major Osteoporotic Fracture Through Month 24', 'timeFrame': '24 Months', 'description': 'Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.'}, {'measure': 'Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12', 'timeFrame': '12 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.'}, {'measure': 'Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24', 'timeFrame': '24 Months', 'description': 'A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.'}, {'measure': 'Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24', 'timeFrame': 'Baseline and Month 24', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24', 'timeFrame': 'Baseline and Month 24', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.'}, {'measure': 'Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24', 'timeFrame': 'Baseline and Month 24', 'description': 'Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases'], 'conditions': ['Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '27641143', 'type': 'BACKGROUND', 'citation': 'Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.'}, {'pmid': '29573473', 'type': 'BACKGROUND', 'citation': 'Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.'}, {'pmid': '31233639', 'type': 'BACKGROUND', 'citation': 'Chavassieux P, Chapurlat R, Portero-Muzy N, Roux JP, Garcia P, Brown JP, Libanati C, Boyce RW, Wang A, Grauer A. Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment. J Bone Miner Res. 2019 Sep;34(9):1597-1608. doi: 10.1002/jbmr.3735. Epub 2019 Jun 24.'}, {'pmid': '29750828', 'type': 'BACKGROUND', 'citation': 'Cosman F, Crittenden DB, Ferrari S, Lewiecki EM, Jaller-Raad J, Zerbini C, Milmont CE, Meisner PD, Libanati C, Grauer A. Romosozumab FRAME Study: A Post Hoc Analysis of the Role of Regional Background Fracture Risk on Nonvertebral Fracture Outcome. J Bone Miner Res. 2018 Aug;33(8):1407-1416. doi: 10.1002/jbmr.3439. Epub 2018 May 11.'}, {'pmid': '30508316', 'type': 'BACKGROUND', 'citation': 'Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.'}, {'pmid': '31168657', 'type': 'BACKGROUND', 'citation': 'Miyauchi A, Dinavahi RV, Crittenden DB, Yang W, Maddox JC, Hamaya E, Nakamura Y, Libanati C, Grauer A, Shimauchi J. Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos. 2019 Jun 5;14(1):59. doi: 10.1007/s11657-019-0608-z.'}, {'pmid': '33057807', 'type': 'BACKGROUND', 'citation': 'Miyauchi A, Hamaya E, Yang W, Nishi K, Libanati C, Tolman C, Shimauchi J. Romosozumab followed by denosumab in Japanese women with high fracture risk in the FRAME trial. J Bone Miner Metab. 2021 Mar;39(2):278-288. doi: 10.1007/s00774-020-01147-5. Epub 2020 Oct 15.'}, {'pmid': '33537844', 'type': 'BACKGROUND', 'citation': 'McCloskey EV, Johansson H, Harvey NC, Lorentzon M, Shi Y, Kanis JA. Romosozumab efficacy on fracture outcomes is greater in patients at high baseline fracture risk: a post hoc analysis of the first year of the frame study. Osteoporos Int. 2021 Aug;32(8):1601-1608. doi: 10.1007/s00198-020-05815-0. Epub 2021 Feb 3.'}, {'pmid': '34633116', 'type': 'BACKGROUND', 'citation': 'Eriksen EF, Chapurlat R, Boyce RW, Shi Y, Brown JP, Horlait S, Betah D, Libanati C, Chavassieux P. Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results From the FRAME Clinical Trial. J Bone Miner Res. 2022 Jan;37(1):36-40. doi: 10.1002/jbmr.4457. Epub 2021 Nov 19.'}, {'pmid': '35466448', 'type': 'BACKGROUND', 'citation': 'Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.'}, {'pmid': '31707465', 'type': 'BACKGROUND', 'citation': 'Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9.'}, {'pmid': '35639174', 'type': 'BACKGROUND', 'citation': 'Miyauchi A, Hamaya E, Nishi K, Tolman C, Shimauchi J. Efficacy and safety of romosozumab among Japanese postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease. J Bone Miner Metab. 2022 Jul;40(4):677-687. doi: 10.1007/s00774-022-01332-8. Epub 2022 May 31.'}, {'pmid': '38640512', 'type': 'BACKGROUND', 'citation': 'Eriksen EF, Boyce RW, Shi Y, Brown JP, Betah D, Libanati C, Oates M, Chapurlat R, Chavassieux P. Reconstruction of remodeling units reveals positive effects after 2 and 12 months of romosozumab treatment. J Bone Miner Res. 2024 Jul 23;39(6):729-736. doi: 10.1093/jbmr/zjae055.'}, {'pmid': '37985218', 'type': 'BACKGROUND', 'citation': 'Lane NE, Betah D, Deignan C, Oates M, Wang Z, Timoshanko J, Khan AA, Binkley N. Effect of Romosozumab Treatment in Postmenopausal Women With Osteoporosis and Knee Osteoarthritis: Results From a Substudy of a Phase 3 Clinical Trial. ACR Open Rheumatol. 2024 Jan;6(1):43-51. doi: 10.1002/acr2.11619. Epub 2023 Nov 20.'}, {'pmid': '37406858', 'type': 'BACKGROUND', 'citation': 'McClung MR, Betah D, Deignan C, Shi Y, Timoshanko J, Cosman F. Romosozumab Efficacy in Postmenopausal Women With No Prior Fracture Who Fulfill Criteria for Very High Fracture Risk. Endocr Pract. 2023 Sep;29(9):716-722. doi: 10.1016/j.eprac.2023.06.011. Epub 2023 Jul 4.'}, {'pmid': '39041711', 'type': 'BACKGROUND', 'citation': 'Cosman F, Oates M, Betah D, Timoshanko J, Wang Z, Ferrari S, McClung MR. Romosozumab followed by denosumab versus denosumab only: a post hoc analysis of FRAME and FRAME extension. J Bone Miner Res. 2024 Sep 2;39(9):1268-1277. doi: 10.1093/jbmr/zjae116.'}, {'pmid': '38573517', 'type': 'DERIVED', 'citation': 'Lane J, Langdahl B, Stone M, Kurth A, Oates M, Timoshanko J, Wang Z, Libanati C, Cosman F. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. Osteoporos Int. 2024 Jul;35(7):1195-1204. doi: 10.1007/s00198-024-07049-w. Epub 2024 Apr 4.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)\n\nExclusion Criteria:\n\n* BMD T-score of ≤ -3.50 at the total hip or femoral neck\n* History of hip fracture\n* Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays\n* Use of agents affecting bone metabolism\n* History of metabolic or bone disease (except osteoporosis)\n* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)\n* Current hyper- or hypocalcemia\n* Current, uncontrolled hyper- or hypothyroidism\n* Current, uncontrolled hyper- or hypoparathyroidism'}, 'identificationModule': {'nctId': 'NCT01575834', 'acronym': 'FRAME', 'briefTitle': 'Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': '20070337'}, 'secondaryIdInfos': [{'id': '2011-001456-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Romosozumab', 'description': 'Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, 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