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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 9:50 PM

Ignite Modification Date: 2025-12-25 @ 7:28 PM

Study NCT ID: NCT00896532

Status: COMPLETED

Last Update Posted: 2022-09-22

First Post: 2009-05-07

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Austria', 'Belgium', 'Canada', 'Denmark', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010024', 'term': 'Osteoporosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D019379', 'term': 'Teriparatide'}, {'id': 'C557282', 'term': 'romosozumab'}, {'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'Adverse events are reported by treatment phase: Romosozumab treatment phase (Baseline [BL] to month 12 and 24); Denosumab extension phase (months 24 to 36); Romosozumab retreatment phase (months 36 to 48); Follow-on phase (months 48 to 72).', 'description': 'The safety subset is based on actual treatment received. One participant randomized to placebo received 1 dose of romosozumab 70 mg in error was subsequently randomized to denosumab and then received romosozumab in the retreatment phase. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed a 5% threshold', 'eventGroups': [{'id': 'EG000', 'title': 'BL-Month 12: Placebo QM', 'description': 'Participants received placebo matching to romosozumab once a month (QM) administered subcutaneously for 12 months.', 'otherNumAtRisk': 30, 'otherNumAffected': 25, 'seriousNumAtRisk': 30, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'BL-Month 12: Placebo Q3M', 'description': 'Participants received placebo matching to romosozumab once every 3 months (Q3M) administered subcutaneously for 12 months.', 'otherNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'BL-Month 12: Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months.', 'otherNumAtRisk': 51, 'otherNumAffected': 38, 'seriousNumAtRisk': 51, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'BL-Month12: Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months.', 'otherNumAtRisk': 54, 'otherNumAffected': 36, 'seriousNumAtRisk': 54, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'BL-Month 12: Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 12 months.', 'otherNumAtRisk': 50, 'otherNumAffected': 46, 'seriousNumAtRisk': 50, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'BL-Month 12: Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 12 months.', 'otherNumAtRisk': 52, 'otherNumAffected': 40, 'seriousNumAtRisk': 52, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'BL-Month 12: Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously every month for 12 months.', 'otherNumAtRisk': 49, 'otherNumAffected': 41, 'seriousNumAtRisk': 49, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'BL-Month 12: Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 12 months.', 'otherNumAtRisk': 53, 'otherNumAffected': 45, 'seriousNumAtRisk': 53, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'BL-Month 12: Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 12 months.', 'otherNumAtRisk': 51, 'otherNumAffected': 40, 'seriousNumAtRisk': 51, 'seriousNumAffected': 6}, {'id': 'EG009', 'title': 'BL-Month 24: Placebo QM', 'description': 'Participants received placebo matching to romosozumab QM administered subcutaneously for 24 months.', 'otherNumAtRisk': 30, 'otherNumAffected': 28, 'seriousNumAtRisk': 30, 'seriousNumAffected': 5}, {'id': 'EG010', 'title': 'BL-Month 24: Placebo Q3M', 'description': 'Participants received placebo matching to romosozumab Q3M administered subcutaneously for 24 months.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 4}, {'id': 'EG011', 'title': 'BL-Month 24: ALN/Romosozumab 140 mg QM', 'description': 'Participants received open-label alendronate (ALN) 70 mg PO QW for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).', 'otherNumAtRisk': 51, 'otherNumAffected': 49, 'seriousNumAtRisk': 51, 'seriousNumAffected': 8}, {'id': 'EG012', 'title': 'BL-Month 24: Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.', 'otherNumAtRisk': 50, 'otherNumAffected': 48, 'seriousNumAtRisk': 50, 'seriousNumAffected': 9}, {'id': 'EG013', 'title': 'BL-Month 24: Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.', 'otherNumAtRisk': 52, 'otherNumAffected': 47, 'seriousNumAtRisk': 52, 'seriousNumAffected': 8}, {'id': 'EG014', 'title': 'BL-Month 24: Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously every month for 24 months.', 'otherNumAtRisk': 49, 'otherNumAffected': 46, 'seriousNumAtRisk': 49, 'seriousNumAffected': 8}, {'id': 'EG015', 'title': 'BL-Month 24: Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.', 'otherNumAtRisk': 53, 'otherNumAffected': 51, 'seriousNumAtRisk': 53, 'seriousNumAffected': 6}, {'id': 'EG016', 'title': 'BL-Month 24: Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.', 'otherNumAtRisk': 51, 'otherNumAffected': 47, 'seriousNumAtRisk': 51, 'seriousNumAffected': 7}, {'id': 'EG017', 'title': 'Month 24-36: Placebo/Placebo', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.', 'otherNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'seriousNumAffected': 2}, {'id': 'EG018', 'title': 'Month 24-36: Placebo/Denosumab', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.', 'otherNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}, {'id': 'EG019', 'title': 'Month 24-36: ALN/Romosozumab/Placebo', 'description': 'Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.', 'otherNumAtRisk': 19, 'otherNumAffected': 12, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}, {'id': 'EG020', 'title': 'Month 24-36: ALN/Romosozumab/Denosumab', 'description': 'Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously every month from months 12-24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.', 'otherNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG021', 'title': 'Month 24-36: Romosozumab/Placebo', 'description': 'Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.', 'otherNumAtRisk': 90, 'otherNumAffected': 57, 'seriousNumAtRisk': 90, 'seriousNumAffected': 3}, {'id': 'EG022', 'title': 'Month 24-36: Romosozumab/Denosumab', 'description': 'Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.', 'otherNumAtRisk': 89, 'otherNumAffected': 59, 'seriousNumAtRisk': 89, 'seriousNumAffected': 8}, {'id': 'EG023', 'title': 'Month 36-48: Placebo/Placebo/Romosozumab', 'description': 'Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG024', 'title': 'Month 36-48: Placebo/Denosumab/Romosozumab', 'description': 'Participants who received placebo in the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).', 'otherNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}, {'id': 'EG025', 'title': 'Month 36-48: Romosozumab/Placebo/Romosozumab', 'description': 'Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).', 'otherNumAtRisk': 72, 'otherNumAffected': 53, 'seriousNumAtRisk': 72, 'seriousNumAffected': 4}, {'id': 'EG026', 'title': 'Month 36-48: Romosozumab/Denosumab/Romosozumab', 'description': 'Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).', 'otherNumAtRisk': 68, 'otherNumAffected': 55, 'seriousNumAtRisk': 68, 'seriousNumAffected': 3}, {'id': 'EG027', 'title': 'Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention', 'description': 'Participants who received romosozumab at any dose during the first 24 month treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72).', 'otherNumAtRisk': 51, 'otherNumAffected': 34, 'seriousNumAtRisk': 51, 'seriousNumAffected': 8}, {'id': 'EG028', 'title': 'Month 48-72: Romosozumab/Placebo/Romosozumab/No', 'description': 'Participants who received romosozumab at any dose during the first 24 month treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 were assigned to the zoledronic acid treatment group, but received no intervention during the 24-month follow-on phase (months 48 to 72).', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG029', 'title': 'Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.', 'otherNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}, {'id': 'EG030', 'title': 'Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.', 'otherNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}, {'id': 'EG031', 'title': 'Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid', 'description': 'Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.', 'otherNumAtRisk': 56, 'otherNumAffected': 44, 'seriousNumAtRisk': 56, 'seriousNumAffected': 9}, {'id': 'EG032', 'title': 'Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid', 'description': 'Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG025', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG028', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG029', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG030', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG031', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG032', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG025', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG028', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG029', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG030', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG031', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG032', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG024', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG025', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG026', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG027', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG028', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG029', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG030', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG031', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG032', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG025', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG028', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG029', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG030', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG031', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG032', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 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{'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}, {'value': '139', 'groupId': 'OG008'}, {'value': '100', 'groupId': 'OG009'}, {'value': '95', 'groupId': 'OG010'}, {'value': '100', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}, {'id': 'OG008', 'title': 'Romosozumab Monthly', 'description': 'Participants who received once a month dosing of romosozumab (70, 140 or 210 mg).'}, {'id': 'OG009', 'title': 'Romosozumab Every 3 Months', 'description': 'Participants who received romosozumab every 3 months (140 or 210 mg)'}, {'id': 'OG010', 'title': 'Romosozumab 140 mg', 'description': 'Participants who received romosozumab 140 mg dosing (QM or Q3M).'}, {'id': 'OG011', 'title': 'Romosozumab 210 mg', 'description': 'Participants who received romosozumab 210 mg dosing (QM or Q3M).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '0.9'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.1'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '8.2'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '6.4'}, {'value': '5.4', 'groupId': 'OG004', 'lowerLimit': '4.4', 'upperLimit': '6.5'}, {'value': '9.1', 'groupId': 'OG005', 'lowerLimit': '8.0', 'upperLimit': '10.2'}, {'value': '5.5', 'groupId': 'OG006', 'lowerLimit': '4.4', 'upperLimit': '6.6'}, {'value': '11.3', 'groupId': 'OG007', 'lowerLimit': '10.3', 'upperLimit': '12.4'}, {'value': '8.6', 'groupId': 'OG008', 'lowerLimit': '7.9', 'upperLimit': '9.3'}, {'value': '5.5', 'groupId': 'OG009', 'lowerLimit': '4.7', 'upperLimit': '6.3'}, {'value': '7.3', 'groupId': 'OG010', 'lowerLimit': '6.4', 'upperLimit': '8.1'}, {'value': '8.4', 'groupId': 'OG011', 'lowerLimit': '7.6', 'upperLimit': '9.2'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG008'], 'paramType': 'LS Mean Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '7.5', 'ciUpperLimit': '9.9', 'pValueComment': 'P-value is adjusted by the Hochberg procedure for comparisons to placebo.', 'groupDescription': 'A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG009'], 'paramType': 'LS Mean Difference from placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '4.3', 'ciUpperLimit': '6.9', 'pValueComment': 'P-value is adjusted by the Hochberg procedure for comparisons to placebo.', 'groupDescription': 'A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG010'], 'paramType': 'LS Mean Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '6.1', 'ciUpperLimit': '8.7', 'pValueComment': 'P-value is adjusted by the Hochberg procedure for comparisons to placebo.', 'groupDescription': 'A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG011'], 'paramType': 'LS Mean Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '7.3', 'ciUpperLimit': '9.8', 'pValueComment': 'P-value is adjusted by the Hochberg procedure for comparisons to placebo.', 'groupDescription': 'A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 12 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '1.3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '3.6'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '5.8'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '5.1'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '3.2', 'upperLimit': '5.2'}, {'value': '7.1', 'groupId': 'OG005', 'lowerLimit': '6.1', 'upperLimit': '8.1'}, {'value': '4.4', 'groupId': 'OG006', 'lowerLimit': '3.4', 'upperLimit': '5.3'}, {'value': '8.2', 'groupId': 'OG007', 'lowerLimit': '7.3', 'upperLimit': '9.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 6 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at Month 6 in BMD of the Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '-0.1'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.5'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-0.0', 'upperLimit': '1.1'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '-0.1', 'upperLimit': '1.1'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '1.5'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '1.7', 'upperLimit': '2.8'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '0.6', 'upperLimit': '1.7'}, {'value': '2.9', 'groupId': 'OG007', 'lowerLimit': '2.3', 'upperLimit': '3.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 6 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at Month 6 in BMD of the Femoral Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.4'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '1.4'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '1.3'}, {'value': '0.2', 'groupId': 'OG003', 'lowerLimit': '-0.7', 'upperLimit': '1.1'}, {'value': '0.4', 'groupId': 'OG004', 'lowerLimit': '-0.4', 'upperLimit': '1.3'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '3.0'}, {'value': '0.9', 'groupId': 'OG006', 'lowerLimit': '0.1', 'upperLimit': '1.7'}, {'value': '1.9', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '2.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 6 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at Month 12 in BMD of the Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.1'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.6'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '2.0'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '2.0'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': '2.0'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': '4.1'}, {'value': '1.9', 'groupId': 'OG006', 'lowerLimit': '1.3', 'upperLimit': '2.6'}, {'value': '4.1', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '4.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 12 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at Month 12 in BMD of the Femoral Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-0.2'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '2.1'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.0'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '-0.3', 'upperLimit': '1.6'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '2.7'}, {'value': '4.2', 'groupId': 'OG005', 'lowerLimit': '3.3', 'upperLimit': '5.1'}, {'value': '1.4', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '2.3'}, {'value': '3.7', 'groupId': 'OG007', 'lowerLimit': '2.8', 'upperLimit': '4.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 12 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at Month 12 in BMD of the Distal Radius', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '0.1'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '0.7'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-2.7', 'upperLimit': '-0.7'}, {'value': '-1.8', 'groupId': 'OG003', 'lowerLimit': '-2.8', 'upperLimit': '-0.8'}, {'value': '-1.1', 'groupId': 'OG004', 'lowerLimit': '-2.1', 'upperLimit': '-0.2'}, {'value': '-1.0', 'groupId': 'OG005', 'lowerLimit': '-2.0', 'upperLimit': '-0.0'}, {'value': '-0.4', 'groupId': 'OG006', 'lowerLimit': '-1.3', 'upperLimit': '0.5'}, {'value': '-1.2', 'groupId': 'OG007', 'lowerLimit': '-2.1', 'upperLimit': '-0.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had non-missing baseline and month 12 measurements.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-8.7', 'upperLimit': '8.1'}, {'value': '24.2', 'groupId': 'OG003', 'lowerLimit': '14.1', 'upperLimit': '35.3'}, {'value': '61.4', 'groupId': 'OG004', 'lowerLimit': '48.6', 'upperLimit': '75.3'}, {'value': '55.0', 'groupId': 'OG005', 'lowerLimit': '42.2', 'upperLimit': '69.0'}, {'value': '75.8', 'groupId': 'OG006', 'lowerLimit': '61.8', 'upperLimit': '90.9'}, {'value': '92.2', 'groupId': 'OG007', 'lowerLimit': '76.6', 'upperLimit': '109.1'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'groupId': 'OG000', 'lowerLimit': '-13.6', 'upperLimit': '3.6'}, {'value': '-50.8', 'groupId': 'OG001', 'lowerLimit': '-55.1', 'upperLimit': '-46.2'}, {'value': '97.1', 'groupId': 'OG002', 'lowerLimit': '79.7', 'upperLimit': '116.1'}, {'value': '-9.1', 'groupId': 'OG003', 'lowerLimit': '-17.1', 'upperLimit': '-0.2'}, {'value': '-15.5', 'groupId': 'OG004', 'lowerLimit': '-22.7', 'upperLimit': '-7.7'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '-5.4', 'upperLimit': '13.9'}, {'value': '-19.5', 'groupId': 'OG006', 'lowerLimit': '-26.4', 'upperLimit': '-12.1'}, {'value': '25.6', 'groupId': 'OG007', 'lowerLimit': '14.6', 'upperLimit': '37.5'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'groupId': 'OG000', 'lowerLimit': '-14.6', 'upperLimit': '3.6'}, {'value': '-57.0', 'groupId': 'OG001', 'lowerLimit': '-61.0', 'upperLimit': '-52.7'}, {'value': '138.0', 'groupId': 'OG002', 'lowerLimit': '115.7', 'upperLimit': '162.6'}, {'value': '-20.0', 'groupId': 'OG003', 'lowerLimit': '-27.7', 'upperLimit': '-11.4'}, {'value': '-22.8', 'groupId': 'OG004', 'lowerLimit': '-29.9', 'upperLimit': '-15.0'}, {'value': '-18.6', 'groupId': 'OG005', 'lowerLimit': '-26.3', 'upperLimit': '-10.1'}, {'value': '-25.5', 'groupId': 'OG006', 'lowerLimit': '-32.2', 'upperLimit': '-18.1'}, {'value': '6.9', 'groupId': 'OG007', 'lowerLimit': '-3.0', 'upperLimit': '17.8'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'groupId': 'OG000', 'lowerLimit': '-19.6', 'upperLimit': '-0.7'}, {'value': '-60.8', 'groupId': 'OG001', 'lowerLimit': '-64.7', 'upperLimit': '-56.5'}, {'value': '116.8', 'groupId': 'OG002', 'lowerLimit': '95.1', 'upperLimit': '140.9'}, {'value': '-26.9', 'groupId': 'OG003', 'lowerLimit': '-34.4', 'upperLimit': '-18.5'}, {'value': '-23.8', 'groupId': 'OG004', 'lowerLimit': '-31.4', 'upperLimit': '-15.4'}, {'value': '-26.1', 'groupId': 'OG005', 'lowerLimit': '-33.6', 'upperLimit': '-17.8'}, {'value': '-30.1', 'groupId': 'OG006', 'lowerLimit': '-36.8', 'upperLimit': '-22.6'}, {'value': '-5.8', 'groupId': 'OG007', 'lowerLimit': '-15.1', 'upperLimit': '4.6'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'groupId': 'OG000', 'lowerLimit': '-17.9', 'upperLimit': '1.5'}, {'value': '-60.8', 'groupId': 'OG001', 'lowerLimit': '-64.7', 'upperLimit': '-56.4'}, {'value': '98.3', 'groupId': 'OG002', 'lowerLimit': '78.3', 'upperLimit': '120.5'}, {'value': '-23.0', 'groupId': 'OG003', 'lowerLimit': '-31.0', 'upperLimit': '-14.0'}, {'value': '-23.3', 'groupId': 'OG004', 'lowerLimit': '-30.9', 'upperLimit': '-14.9'}, {'value': '-31.2', 'groupId': 'OG005', 'lowerLimit': '-38.2', 'upperLimit': '-23.4'}, {'value': '-29.7', 'groupId': 'OG006', 'lowerLimit': '-36.7', 'upperLimit': '-22.1'}, {'value': '-17.2', 'groupId': 'OG007', 'lowerLimit': '-25.4', 'upperLimit': '-8.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'groupId': 'OG000', 'lowerLimit': '-12.1', 'upperLimit': '5.1'}, {'value': '-22.1', 'groupId': 'OG003', 'lowerLimit': '-28.9', 'upperLimit': '-14.7'}, {'value': '-19.2', 'groupId': 'OG004', 'lowerLimit': '-26.0', 'upperLimit': '-11.7'}, {'value': '-35.4', 'groupId': 'OG005', 'lowerLimit': '-41.0', 'upperLimit': '-29.2'}, {'value': '-33.0', 'groupId': 'OG006', 'lowerLimit': '-38.6', 'upperLimit': '-26.8'}, {'value': '-28.5', 'groupId': 'OG007', 'lowerLimit': '-34.7', 'upperLimit': '-21.8'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '8.2'}, {'value': '-65.0', 'groupId': 'OG001', 'lowerLimit': '-68.5', 'upperLimit': '-61.1'}, {'value': '69.4', 'groupId': 'OG002', 'lowerLimit': '52.6', 'upperLimit': '88.0'}, {'value': '-21.5', 'groupId': 'OG003', 'lowerLimit': '-29.3', 'upperLimit': '-12.8'}, {'value': '-6.2', 'groupId': 'OG004', 'lowerLimit': '-15.2', 'upperLimit': '3.8'}, {'value': '-26.5', 'groupId': 'OG005', 'lowerLimit': '-33.8', 'upperLimit': '-18.3'}, {'value': '-12.6', 'groupId': 'OG006', 'lowerLimit': '-21.0', 'upperLimit': '-3.4'}, {'value': '-3.7', 'groupId': 'OG007', 'lowerLimit': '-13.2', 'upperLimit': '6.7'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-8.4', 'upperLimit': '15.2'}, {'value': '-64.2', 'groupId': 'OG001', 'lowerLimit': '-68.1', 'upperLimit': '-59.8'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '72.3', 'upperLimit': '117.4'}, {'value': '-18.1', 'groupId': 'OG003', 'lowerLimit': '-27.3', 'upperLimit': '-7.7'}, {'value': '-8.4', 'groupId': 'OG004', 'lowerLimit': '-18.3', 'upperLimit': '2.7'}, {'value': '-24.6', 'groupId': 'OG005', 'lowerLimit': '-33.0', 'upperLimit': '-15.2'}, {'value': '-10.5', 'groupId': 'OG006', 'lowerLimit': '-20.0', 'upperLimit': '0.0'}, {'value': '-8.7', 'groupId': 'OG007', 'lowerLimit': '-18.6', 'upperLimit': '2.4'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '14.9'}, {'value': '-64.4', 'groupId': 'OG001', 'lowerLimit': '-68.6', 'upperLimit': '-59.5'}, {'value': '81.3', 'groupId': 'OG002', 'lowerLimit': '59.4', 'upperLimit': '106.2'}, {'value': '-15.1', 'groupId': 'OG003', 'lowerLimit': '-25.7', 'upperLimit': '-3.0'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '-10.8', 'upperLimit': '15.1'}, {'value': '-27.7', 'groupId': 'OG005', 'lowerLimit': '-36.6', 'upperLimit': '-17.6'}, {'value': '-11.7', 'groupId': 'OG006', 'lowerLimit': '-22.0', 'upperLimit': '-0.1'}, {'value': '-17.2', 'groupId': 'OG007', 'lowerLimit': '-27.1', 'upperLimit': '-6.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '25.4'}, {'value': '-66.7', 'groupId': 'OG001', 'lowerLimit': '-70.8', 'upperLimit': '-62.0'}, {'value': '77.0', 'groupId': 'OG002', 'lowerLimit': '54.9', 'upperLimit': '102.1'}, {'value': '-20.3', 'groupId': 'OG003', 'lowerLimit': '-30.6', 'upperLimit': '-8.6'}, {'value': '12.2', 'groupId': 'OG004', 'lowerLimit': '-1.5', 'upperLimit': '27.8'}, {'value': '-33.0', 'groupId': 'OG005', 'lowerLimit': '-41.4', 'upperLimit': '-23.3'}, {'value': '-6.6', 'groupId': 'OG006', 'lowerLimit': '-18.0', 'upperLimit': '6.5'}, {'value': '-22.5', 'groupId': 'OG007', 'lowerLimit': '-32.0', 'upperLimit': '-11.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-9.1', 'upperLimit': '6.5'}, {'value': '28.1', 'groupId': 'OG003', 'lowerLimit': '18.3', 'upperLimit': '38.7'}, {'value': '60.1', 'groupId': 'OG004', 'lowerLimit': '48.2', 'upperLimit': '73.0'}, {'value': '53.1', 'groupId': 'OG005', 'lowerLimit': '41.2', 'upperLimit': '65.9'}, {'value': '77.9', 'groupId': 'OG006', 'lowerLimit': '64.7', 'upperLimit': '92.2'}, {'value': '78.6', 'groupId': 'OG007', 'lowerLimit': '65.0', 'upperLimit': '93.2'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '14.7'}, {'value': '-28.7', 'groupId': 'OG001', 'lowerLimit': '-35.3', 'upperLimit': '-21.5'}, {'value': '104.7', 'groupId': 'OG002', 'lowerLimit': '85.5', 'upperLimit': '125.9'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-9.8', 'upperLimit': '10.1'}, {'value': '-5.6', 'groupId': 'OG004', 'lowerLimit': '-14.2', 'upperLimit': '3.8'}, {'value': '15.6', 'groupId': 'OG005', 'lowerLimit': '4.7', 'upperLimit': '27.7'}, {'value': '-3.7', 'groupId': 'OG006', 'lowerLimit': '-12.5', 'upperLimit': '5.9'}, {'value': '41.6', 'groupId': 'OG007', 'lowerLimit': '28.4', 'upperLimit': '56.1'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-7.1', 'groupId': 'OG000', 'lowerLimit': '-16.2', 'upperLimit': '2.8'}, {'value': '-40.6', 'groupId': 'OG001', 'lowerLimit': '-46.3', 'upperLimit': '-34.2'}, {'value': '106.7', 'groupId': 'OG002', 'lowerLimit': '86.5', 'upperLimit': '129.1'}, {'value': '-11.8', 'groupId': 'OG003', 'lowerLimit': '-20.8', 'upperLimit': '-1.8'}, {'value': '-16.5', 'groupId': 'OG004', 'lowerLimit': '-24.5', 'upperLimit': '-7.6'}, {'value': '-7.4', 'groupId': 'OG005', 'lowerLimit': '-16.5', 'upperLimit': '2.8'}, {'value': '-23.2', 'groupId': 'OG006', 'lowerLimit': '-30.5', 'upperLimit': '-15.3'}, {'value': '10.0', 'groupId': 'OG007', 'lowerLimit': '-0.7', 'upperLimit': '21.7'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'groupId': 'OG000', 'lowerLimit': '-15.0', 'upperLimit': '4.0'}, {'value': '-50.9', 'groupId': 'OG001', 'lowerLimit': '-55.6', 'upperLimit': '-45.8'}, {'value': '99.9', 'groupId': 'OG002', 'lowerLimit': '80.8', 'upperLimit': '121.0'}, {'value': '-26.9', 'groupId': 'OG003', 'lowerLimit': '-34.1', 'upperLimit': '-18.9'}, {'value': '-29.0', 'groupId': 'OG004', 'lowerLimit': '-35.8', 'upperLimit': '-21.6'}, {'value': '-27.7', 'groupId': 'OG005', 'lowerLimit': '-34.7', 'upperLimit': '-19.9'}, {'value': '-30.7', 'groupId': 'OG006', 'lowerLimit': '-37.1', 'upperLimit': '-23.7'}, {'value': '-4.0', 'groupId': 'OG007', 'lowerLimit': '-13.1', 'upperLimit': '6.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-14.1', 'groupId': 'OG000', 'lowerLimit': '-22.0', 'upperLimit': '-5.4'}, {'value': '-50.3', 'groupId': 'OG001', 'lowerLimit': '-54.8', 'upperLimit': '-45.4'}, {'value': '91.6', 'groupId': 'OG002', 'lowerLimit': '74.1', 'upperLimit': '110.9'}, {'value': '-27.3', 'groupId': 'OG003', 'lowerLimit': '-34.1', 'upperLimit': '-19.6'}, {'value': '-24.7', 'groupId': 'OG004', 'lowerLimit': '-31.4', 'upperLimit': '-17.2'}, {'value': '-31.1', 'groupId': 'OG005', 'lowerLimit': '-37.5', 'upperLimit': '-24.1'}, {'value': '-26.2', 'groupId': 'OG006', 'lowerLimit': '-32.9', 'upperLimit': '-18.9'}, {'value': '-12.5', 'groupId': 'OG007', 'lowerLimit': '-20.4', 'upperLimit': '-3.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'OG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'OG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'OG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'OG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'OG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'OG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '4.9'}, {'value': '11.7', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '18.5'}, {'value': '35.1', 'groupId': 'OG004', 'lowerLimit': '27.5', 'upperLimit': '43.1'}, {'value': '29.3', 'groupId': 'OG005', 'lowerLimit': '21.8', 'upperLimit': '37.3'}, {'value': '47.5', 'groupId': 'OG006', 'lowerLimit': '39.3', 'upperLimit': '56.2'}, {'value': '60.9', 'groupId': 'OG007', 'lowerLimit': '51.7', 'upperLimit': '70.7'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '50', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-7.6', 'groupId': 'OG000', 'lowerLimit': '-14.3', 'upperLimit': '-0.3'}, {'value': '-30.5', 'groupId': 'OG001', 'lowerLimit': '-35.5', 'upperLimit': '-25.0'}, {'value': '21.8', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '31.4'}, {'value': '-8.5', 'groupId': 'OG003', 'lowerLimit': '-15.3', 'upperLimit': '-1.1'}, {'value': '-18.0', 'groupId': 'OG004', 'lowerLimit': '-23.9', 'upperLimit': '-11.7'}, {'value': '1.3', 'groupId': 'OG005', 'lowerLimit': '-6.2', 'upperLimit': '9.4'}, {'value': '-17.3', 'groupId': 'OG006', 'lowerLimit': '-23.2', 'upperLimit': '-10.9'}, {'value': '27.4', 'groupId': 'OG007', 'lowerLimit': '18.1', 'upperLimit': '37.4'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'groupId': 'OG000', 'lowerLimit': '-12.1', 'upperLimit': '4.5'}, {'value': '-35.4', 'groupId': 'OG001', 'lowerLimit': '-40.8', 'upperLimit': '-29.7'}, {'value': '29.8', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '41.6'}, {'value': '-8.7', 'groupId': 'OG003', 'lowerLimit': '-16.6', 'upperLimit': '-0.1'}, {'value': '-18.2', 'groupId': 'OG004', 'lowerLimit': '-25.0', 'upperLimit': '-10.9'}, {'value': '-6.6', 'groupId': 'OG005', 'lowerLimit': '-14.5', 'upperLimit': '2.0'}, {'value': '-20.0', 'groupId': 'OG006', 'lowerLimit': '-26.4', 'upperLimit': '-13.0'}, {'value': '13.1', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '23.3'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '11.4'}, {'value': '-32.5', 'groupId': 'OG001', 'lowerLimit': '-37.3', 'upperLimit': '-27.4'}, {'value': '41.8', 'groupId': 'OG002', 'lowerLimit': '31.7', 'upperLimit': '52.6'}, {'value': '-4.9', 'groupId': 'OG003', 'lowerLimit': '-11.9', 'upperLimit': '2.6'}, {'value': '-12.5', 'groupId': 'OG004', 'lowerLimit': '-18.7', 'upperLimit': '-5.9'}, {'value': '-5.5', 'groupId': 'OG005', 'lowerLimit': '-12.3', 'upperLimit': '1.8'}, {'value': '-17.7', 'groupId': 'OG006', 'lowerLimit': '-23.3', 'upperLimit': '-11.7'}, {'value': '10.4', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '18.8'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '17.2'}, {'value': '-31.2', 'groupId': 'OG001', 'lowerLimit': '-35.9', 'upperLimit': '-26.2'}, {'value': '45.7', 'groupId': 'OG002', 'lowerLimit': '35.7', 'upperLimit': '56.4'}, {'value': '-2.6', 'groupId': 'OG003', 'lowerLimit': '-9.5', 'upperLimit': '4.8'}, {'value': '-10.8', 'groupId': 'OG004', 'lowerLimit': '-16.9', 'upperLimit': '-4.4'}, {'value': '-5.0', 'groupId': 'OG005', 'lowerLimit': '-11.6', 'upperLimit': '2.1'}, {'value': '-12.4', 'groupId': 'OG006', 'lowerLimit': '-18.3', 'upperLimit': '-6.1'}, {'value': '9.2', 'groupId': 'OG007', 'lowerLimit': '1.8', 'upperLimit': '17.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and at least one post baseline measurement on or prior to the month 12 visit and with available data at each time point. Data were not collected for participants in the alendronate and teriparatide groups at month 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'FG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'FG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'FG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'FG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'FG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'FG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'FG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}, {'id': 'FG008', 'title': 'Month 24-36: Placebo/Placebo', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months (Q6M) for 12 months during the denosumab extension phase.'}, {'id': 'FG009', 'title': 'Month 24-36: Placebo/Denosumab', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.'}, {'id': 'FG010', 'title': 'Month 24-36: Alendronate/Romosozumab/Placebo', 'description': 'Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.'}, {'id': 'FG011', 'title': 'Month 24-36: Alendronate/Romosozumab/Denosumab', 'description': 'Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously QM from months 12 to 24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.'}, {'id': 'FG012', 'title': 'Month 24-36: Romosozumab/Placebo', 'description': 'Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase.'}, {'id': 'FG013', 'title': 'Month 24-36: Romosozumab/Denosumab', 'description': 'Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase.'}, {'id': 'FG014', 'title': 'Month 36-48: Placebo/Placebo/Romosozumab', 'description': 'Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24-36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).'}, {'id': 'FG015', 'title': 'Month 36-48: Placebo/Denosumab/Romosozumab', 'description': 'Participants who received placebo in the first 24 month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).'}, {'id': 'FG016', 'title': 'Month 36-48: Romosozumab/Placebo/Romosozumab', 'description': 'Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).'}, {'id': 'FG017', 'title': 'Month 36-48: Romosozumab/Denosumab/Romosozumab', 'description': 'Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48).'}, {'id': 'FG018', 'title': 'Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention', 'description': 'Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72).'}, {'id': 'FG019', 'title': 'Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.'}, {'id': 'FG020', 'title': 'Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic Acid', 'description': 'Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.'}, {'id': 'FG021', 'title': 'Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid', 'description': 'Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.'}, {'id': 'FG022', 'title': 'Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid', 'description': 'Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48.'}], 'periods': [{'title': 'Months 1-24: Romosozumab Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '54'}, {'groupId': 'FG005', 'numSubjects': '51'}, {'groupId': 'FG006', 'numSubjects': '53'}, {'groupId': 'FG007', 'numSubjects': '52'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': 'One participant received 1 dose of romosozumab 70 mg in error', 'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '48'}, {'groupId': 'FG006', 'numSubjects': '53'}, {'groupId': 'FG007', 'numSubjects': '51'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Completed 12 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '51'}, {'groupId': 'FG007', 'numSubjects': '49'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '43'}, {'groupId': 'FG006', 'numSubjects': '48'}, {'groupId': 'FG007', 'numSubjects': '48'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 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'0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'On-study But No Month 24 Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 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{'groupId': 'FG010', 'numSubjects': '18'}, {'groupId': 'FG011', 'numSubjects': '19'}, {'groupId': 'FG012', 'numSubjects': '88'}, {'groupId': 'FG013', 'numSubjects': '88'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 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{'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 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'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}]}, {'title': 'Months 36-48: Romosozumab Retreatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '12'}, {'groupId': 'FG015', 'numSubjects': '16'}, {'groupId': 'FG016', 'numSubjects': '72'}, {'groupId': 'FG017', 'numSubjects': '67'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Received Romosozumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '12'}, {'comment': 'Includes one participant who received 1 dose of romosozumab 70 mg in error in first 12 months', 'groupId': 'FG015', 'numSubjects': '16'}, {'groupId': 'FG016', 'numSubjects': '72'}, {'groupId': 'FG017', 'numSubjects': '67'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '12'}, {'groupId': 'FG015', 'numSubjects': '14'}, {'groupId': 'FG016', 'numSubjects': '65'}, {'groupId': 'FG017', 'numSubjects': '64'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '7'}, {'groupId': 'FG017', 'numSubjects': '3'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '2'}, {'groupId': 'FG017', 'numSubjects': '2'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Continuing the re-treatment phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}]}, {'title': 'Months 48-72: Follow-on Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '51'}, {'groupId': 'FG019', 'numSubjects': '11'}, {'groupId': 'FG020', 'numSubjects': '12'}, {'groupId': 'FG021', 'numSubjects': '59'}, {'groupId': 'FG022', 'numSubjects': '8'}]}, {'type': 'Received Zoledronic Acid', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '11'}, {'groupId': 'FG020', 'numSubjects': '12'}, {'groupId': 'FG021', 'numSubjects': '56'}, {'groupId': 'FG022', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '50'}, {'groupId': 'FG019', 'numSubjects': '11'}, {'groupId': 'FG020', 'numSubjects': '12'}, {'groupId': 'FG021', 'numSubjects': '57'}, {'groupId': 'FG022', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '2'}, {'groupId': 'FG022', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Ineligibility Determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '1'}, {'groupId': 'FG022', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '1'}, {'groupId': 'FG022', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 29 centers in 7 countries in Europe, North America, and Argentina. Participants were enrolled from the 3rd of June 2009 to the 17th of February 2010.', 'preAssignmentDetails': 'A total of 807 patients were screened and 419 were randomized. The study included a 24-month treatment phase, followed by rerandomization to a 12-month extension phase with denosumab or placebo; followed by a 12-month retreatment phase with romosozumab, followed by a 24-month follow-on phase with zoledronic acid or no intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously for 24 months.'}, {'id': 'BG001', 'title': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).'}, {'id': 'BG002', 'title': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.'}, {'id': 'BG003', 'title': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.'}, {'id': 'BG004', 'title': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.'}, {'id': 'BG005', 'title': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.'}, {'id': 'BG006', 'title': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.'}, {'id': 'BG007', 'title': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '67.0', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '5.7', 'groupId': 'BG002'}, {'value': '65.8', 'spread': '6.1', 'groupId': 'BG003'}, {'value': '67.3', 'spread': '6.7', 'groupId': 'BG004'}, {'value': '67.8', 'spread': '6.2', 'groupId': 'BG005'}, {'value': '66.1', 'spread': '7.3', 'groupId': 'BG006'}, {'value': '66.3', 'spread': '6.5', 'groupId': 'BG007'}, {'value': '66.8', 'spread': '6.4', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'title': '< 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '154', 'groupId': 'BG008'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}, {'value': '265', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'title': 'White or Caucasian', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}, {'value': '362', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}, {'title': 'Japanese', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lumbar Spine Bone Mineral Density (BMD) T-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '-2.29', 'spread': '0.66', 'groupId': 'BG000'}, {'value': '-2.08', 'spread': '0.69', 'groupId': 'BG001'}, {'value': '-2.29', 'spread': '0.57', 'groupId': 'BG002'}, {'value': '-2.35', 'spread': '0.79', 'groupId': 'BG003'}, {'value': '-2.44', 'spread': '0.70', 'groupId': 'BG004'}, {'value': '-2.27', 'spread': '0.77', 'groupId': 'BG005'}, {'value': '-2.21', 'spread': '0.69', 'groupId': 'BG006'}, {'value': '-2.33', 'spread': '0.57', 'groupId': 'BG007'}, {'value': '-2.29', 'spread': '0.68', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. A normal T-score is -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Hip BMD T-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.67', 'groupId': 'BG000'}, {'value': '-1.55', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '-1.32', 'spread': '0.78', 'groupId': 'BG002'}, {'value': '-1.69', 'spread': '0.67', 'groupId': 'BG003'}, {'value': '-1.58', 'spread': '0.51', 'groupId': 'BG004'}, {'value': '-1.67', 'spread': '0.65', 'groupId': 'BG005'}, {'value': '-1.65', 'spread': '0.63', 'groupId': 'BG006'}, {'value': '-1.45', 'spread': '0.65', 'groupId': 'BG007'}, {'value': '-1.53', 'spread': '0.66', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Femoral Neck BMD T-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '419', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '-1.76', 'spread': '0.56', 'groupId': 'BG000'}, {'value': '-1.91', 'spread': '0.61', 'groupId': 'BG001'}, {'value': '-1.79', 'spread': '0.67', 'groupId': 'BG002'}, {'value': '-2.06', 'spread': '0.55', 'groupId': 'BG003'}, {'value': '-2.00', 'spread': '0.54', 'groupId': 'BG004'}, {'value': '-2.03', 'spread': '0.58', 'groupId': 'BG005'}, {'value': '-2.02', 'spread': '0.57', 'groupId': 'BG006'}, {'value': '-1.87', 'spread': '0.58', 'groupId': 'BG007'}, {'value': '-1.93', 'spread': '0.59', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Distal 1/3 Radius BMD T-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}, {'value': '49', 'groupId': 'BG007'}, {'value': '400', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '-1.85', 'spread': '1.04', 'groupId': 'BG000'}, {'value': '-2.08', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '-2.05', 'spread': '1.21', 'groupId': 'BG002'}, {'value': '-1.78', 'spread': '1.14', 'groupId': 'BG003'}, {'value': '-2.24', 'spread': '1.06', 'groupId': 'BG004'}, {'value': '-2.11', 'spread': '1.12', 'groupId': 'BG005'}, {'value': '-1.98', 'spread': '1.04', 'groupId': 'BG006'}, {'value': '-2.03', 'spread': '0.99', 'groupId': 'BG007'}, {'value': '-2.01', 'spread': '1.08', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Serum Type 1 Collagen C-telopeptide (CTX)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}, {'value': '410', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '481.0', 'groupId': 'BG000', 'lowerLimit': '347.0', 'upperLimit': '673.0'}, {'value': '494.0', 'groupId': 'BG001', 'lowerLimit': '373.0', 'upperLimit': '614.0'}, {'value': '505.5', 'groupId': 'BG002', 'lowerLimit': '410.0', 'upperLimit': '690.0'}, {'value': '486.0', 'groupId': 'BG003', 'lowerLimit': '374.0', 'upperLimit': '627.0'}, {'value': '525.0', 'groupId': 'BG004', 'lowerLimit': '358.0', 'upperLimit': '714.0'}, {'value': '532.0', 'groupId': 'BG005', 'lowerLimit': '363.0', 'upperLimit': '621.5'}, {'value': '478.0', 'groupId': 'BG006', 'lowerLimit': '362.0', 'upperLimit': '695.0'}, {'value': '519.0', 'groupId': 'BG007', 'lowerLimit': '405.0', 'upperLimit': '642.0'}, {'value': '501.5', 'groupId': 'BG008', 'lowerLimit': '379.0', 'upperLimit': '649.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Participants with available data'}, {'title': 'Serum Procollagen Type 1 N-telopeptide (P1NP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}, {'value': '410', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '47.76', 'groupId': 'BG000', 'lowerLimit': '37.92', 'upperLimit': '59.12'}, {'value': '49.25', 'groupId': 'BG001', 'lowerLimit': '40.05', 'upperLimit': '57.73'}, {'value': '48.78', 'groupId': 'BG002', 'lowerLimit': '42.45', 'upperLimit': '66.98'}, {'value': '50.36', 'groupId': 'BG003', 'lowerLimit': '36.43', 'upperLimit': '61.39'}, {'value': '48.63', 'groupId': 'BG004', 'lowerLimit': '37.55', 'upperLimit': '67.47'}, {'value': '48.13', 'groupId': 'BG005', 'lowerLimit': '38.45', 'upperLimit': '56.30'}, {'value': '49.24', 'groupId': 'BG006', 'lowerLimit': '39.57', 'upperLimit': '62.16'}, {'value': '52.58', 'groupId': 'BG007', 'lowerLimit': '42.47', 'upperLimit': '63.91'}, {'value': '49.37', 'groupId': 'BG008', 'lowerLimit': '39.57', 'upperLimit': '61.86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Participants with available data'}, {'title': 'Osteocalcin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}, {'value': '410', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '17.95', 'groupId': 'BG000', 'lowerLimit': '15.78', 'upperLimit': '23.62'}, {'value': '19.37', 'groupId': 'BG001', 'lowerLimit': '14.69', 'upperLimit': '24.78'}, {'value': '19.47', 'groupId': 'BG002', 'lowerLimit': '15.93', 'upperLimit': '26.14'}, {'value': '19.03', 'groupId': 'BG003', 'lowerLimit': '15.10', 'upperLimit': '23.63'}, {'value': '19.93', 'groupId': 'BG004', 'lowerLimit': '14.92', 'upperLimit': '26.72'}, {'value': '18.56', 'groupId': 'BG005', 'lowerLimit': '15.20', 'upperLimit': '21.92'}, {'value': '17.72', 'groupId': 'BG006', 'lowerLimit': '13.61', 'upperLimit': '23.16'}, {'value': '18.36', 'groupId': 'BG007', 'lowerLimit': '16.15', 'upperLimit': '28.32'}, {'value': '18.84', 'groupId': 'BG008', 'lowerLimit': '15.13', 'upperLimit': '24.16'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Participants with available data'}, {'title': 'Bone-specific Alkaline Phosphatase (BSAP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}, {'value': '410', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '11.79', 'groupId': 'BG000', 'lowerLimit': '9.75', 'upperLimit': '13.53'}, {'value': '12.93', 'groupId': 'BG001', 'lowerLimit': '10.48', 'upperLimit': '15.52'}, {'value': '13.34', 'groupId': 'BG002', 'lowerLimit': '10.04', 'upperLimit': '16.39'}, {'value': '11.82', 'groupId': 'BG003', 'lowerLimit': '10.66', 'upperLimit': '15.34'}, {'value': '13.19', 'groupId': 'BG004', 'lowerLimit': '10.10', 'upperLimit': '15.68'}, {'value': '11.78', 'groupId': 'BG005', 'lowerLimit': '9.44', 'upperLimit': '14.60'}, {'value': '12.61', 'groupId': 'BG006', 'lowerLimit': '10.06', 'upperLimit': '14.04'}, {'value': '12.37', 'groupId': 'BG007', 'lowerLimit': '10.16', 'upperLimit': '15.90'}, {'value': '12.44', 'groupId': 'BG008', 'lowerLimit': '10.06', 'upperLimit': '15.30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Participants with available data'}], 'populationDescription': 'All randomized participants (full analysis set)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 419}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2013-04-16', 'completionDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2009-05-07', 'dispFirstSubmitQcDate': '2013-04-16', 'resultsFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2009-05-07', 'dispFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-20', 'studyFirstPostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine', 'timeFrame': 'Baseline to 6 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.'}, {'measure': 'Percent Change From Baseline at Month 6 in BMD of the Total Hip', 'timeFrame': 'Baseline to 6 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.'}, {'measure': 'Percent Change From Baseline at Month 6 in BMD of the Femoral Neck', 'timeFrame': 'Baseline to 6 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.'}, {'measure': 'Percent Change From Baseline at Month 12 in BMD of the Total Hip', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.'}, {'measure': 'Percent Change From Baseline at Month 12 in BMD of the Femoral Neck', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.'}, {'measure': 'Percent Change From Baseline at Month 12 in BMD of the Distal Radius', 'timeFrame': 'Baseline to 12 months', 'description': 'Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.\n\nPercent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables.'}, {'measure': 'Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.'}, {'measure': 'Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.'}, {'measure': 'Percent Change From Baseline in Osteocalcin', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.'}, {'measure': 'Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)', 'timeFrame': 'Baseline and months 1, 3, 6, 9, and 12', 'description': 'Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Bone Mineral Density', 'Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '27487526', 'type': 'BACKGROUND', 'citation': 'Genant HK, Engelke K, Bolognese MA, Mautalen C, Brown JP, Recknor C, Goemaere S, Fuerst T, Yang YC, Grauer A, Libanati C. Effects of Romosozumab Compared With Teriparatide on Bone Density and Mass at the Spine and Hip in Postmenopausal Women With Low Bone Mass. J Bone Miner Res. 2017 Jan;32(1):181-187. doi: 10.1002/jbmr.2932. Epub 2016 Sep 20.'}, {'pmid': '28543940', 'type': 'BACKGROUND', 'citation': 'Keaveny TM, Crittenden DB, Bolognese MA, Genant HK, Engelke K, Oliveri B, Brown JP, Langdahl BL, Yan C, Grauer A, Libanati C. Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass. J Bone Miner Res. 2017 Sep;32(9):1956-1962. doi: 10.1002/jbmr.3176. Epub 2017 Jun 26.'}, {'pmid': '31628490', 'type': 'BACKGROUND', 'citation': 'Kendler DL, Bone HG, Massari F, Gielen E, Palacios S, Maddox J, Yan C, Yue S, Dinavahi RV, Libanati C, Grauer A. Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab. Osteoporos Int. 2019 Dec;30(12):2437-2448. doi: 10.1007/s00198-019-05146-9. Epub 2019 Oct 18.'}, {'pmid': '29694685', 'type': 'BACKGROUND', 'citation': 'McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, Bolognese MA, Goemaere S, Bone HG, Zanchetta JR, Maddox J, Bray S, Grauer A. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 Aug;33(8):1397-1406. doi: 10.1002/jbmr.3452. Epub 2018 May 22.'}, {'pmid': '32623487', 'type': 'BACKGROUND', 'citation': 'McClung MR, Bolognese MA, Brown JP, Reginster JY, Langdahl BL, Maddox J, Shi Y, Rojeski M, Meisner PD, Grauer A. A single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab. Osteoporos Int. 2020 Nov;31(11):2231-2241. doi: 10.1007/s00198-020-05502-0. Epub 2020 Jul 4.'}, {'pmid': '34258507', 'type': 'BACKGROUND', 'citation': 'McClung MR, Bolognese MA, Brown JP, Reginster JY, Langdahl BL, Shi Y, Timoshanko J, Libanati C, Chines A, Oates MK. Skeletal responses to romosozumab after 12 months of denosumab. JBMR Plus. 2021 Jun 3;5(7):e10512. doi: 10.1002/jbm4.10512. eCollection 2021 Jul.'}, {'pmid': '34738660', 'type': 'BACKGROUND', 'citation': 'Poole KE, Treece GM, Pearson RA, Gee AH, Bolognese MA, Brown JP, Goemaere S, Grauer A, Hanley DA, Mautalen C, Recknor C, Yang YC, Rojeski M, Libanati C, Whitmarsh T. Romosozumab Enhances Vertebral Bone Structure in Women With Low Bone Density. J Bone Miner Res. 2022 Feb;37(2):256-264. doi: 10.1002/jbmr.4465. Epub 2021 Dec 16.'}, {'pmid': '24382002', 'type': 'DERIVED', 'citation': 'McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 Jan 30;370(5):412-20. doi: 10.1056/NEJMoa1305224. Epub 2014 Jan 1.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.', 'detailedDescription': 'This study included a 24-month treatment phase followed by rerandomization to a 12-month extension phase with denosumab or placebo, followed by a 12-month retreatment phase with romosozumab, followed by a 24-month follow-on phase with zoledronic acid or no intervention.\n\n* 24-month Romosozumab Treatment Phase (months 1 to 24): Participants were randomized in a 1:1:1:1:1:1:1:1 ratio to receive 1 of 5 double-blind dosing regimens of romosozumab or placebo or open-label alendronate (ALN) or open-label teriparatide (TPTD) for the first 12 months of the study. At month 12, participants in the romosozumab and placebo groups continued their assigned treatment for an additional 12 months, participants in the TPTD group ended study participation, and participants in the ALN group transitioned to receive romosozumab 140 mg subcutaneously (SC) every month (QM) for an additional 12 months (months 12 to 24).\n* 12-month Denosumab Extension Phase (months 24 to 36): At the end of the 24-month romosozumab treatment phase, eligible participants were randomized 1:1 within their original treatment group to receive either denosumab or placebo every 6 months (Q6M) for 12 months.\n* 12-month Romosozumab Retreatment Phase (months 36 to 48): From months 36 to 48, participants initially randomized to romosozumab or placebo received romosozumab 210 mg SC QM. Participants who initially received ALN ended their participation at month 36 and were not retreated with romosozumab.\n* 24-month Follow-on Phase (months 48 to 72): At month 48, participants received 1 dose of zoledronic acid 5 mg intravenously or no intervention for an additional 24 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulatory, postmenopausal women, aged ≥ 55 to ≤ 85\n* Low BMD measured by dual energy X-ray absorptiometry (DXA) and assessed by the central imaging vendor (equivalent to T-scores between -2.0 and -3.5)\n\nExclusion Criteria:\n\n* History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50\n* Untreated hyper- or hypothyroidism\n* Current hyper- or hypoparathyroidism, hypo- or hypercalcemia\n* Elevated transaminases\n* Significantly impaired renal function\n* Positive for: human immunodeficiency virus (HIV), hepatitis-C or hepatitis-B surface antigen\n* Malignancy\n* History of solid organ or bone marrow transplants\n* Use of agents affecting bone metabolism\n* Contraindicated or intolerant of alendronate therapy\n* Contraindicated or intolerant of teriparatide therapy\n\nInclusion Criteria for the 12 month extension phase (Month 24 to 36):\n\n\\- Normocalcemia at or after the Month 21 visit but before the Month 24 study visit\n\nExclusion Criteria for the 12 month extension phase (Month 24 to 36)\n\n* Incidence of a clinical vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis during the initial 24 month treatment phase of the study\n* A BMD loss of ≥ 7.0% from baseline at any time up to the Month 18 visit of the initial 24-month treatment phase\n* Malignancy\n* History of osteonecrosis of the jaw\n* Use of proscribed medication during the initial 24 month treatment phase\n* Contraindicated or intolerant of denosumab therapy\n\nInclusion Criteria for the 12 month re-treatment phase (Month 36 to 48)\n\n* Albumin adjusted serum calcium of the most recent blood draw at or after the Month 30 visit but before the Month 36 study visit. Calcium repletion is permitted and central laboratory analysis of albumin adjusted serum calcium may be repeated before the Month 36 study visit\n* Participation in Group A or B during initial 24 month treatment phase\n* Subject has reached M36 of the study\n* Appropriate written informed consent must be obtained\n\nExclusion Criteria for the 12 month re-treatment phase (Month 36 to 48)\n\n* New malignancy\n* Use of proscribed medication during the 12 month extension phase\n\nInclusion Criteria for the 24 month follow-on phase (Month 48 to 72) General inclusion criteria for participation\n\n* Subject has reached month 48 of the study\n* Appropriate written informed consent must be obtained Inclusion criteria for assignment to the no intervention group\n* During the 24 month AMG 785 treatment phase, subject was assigned to any AMG 785 treatment group\n* During the 12 month denosumab extension phase, subject was assigned to the denosumab treatment group Exclusion for the 24 month follow-on phase (Month 48 to 72)\n* New malignancy\n* Use of proscribed meds during the 12 month re-treatment phase\n* Partial informed consent withdrawal and discontinuation of investigational product at any time up to month 48 visit\n* Incidence of a clinical vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis during the initial 24 month treatment phase of the study\n* BMD T-score of ≤ -2.5 at the lumbar spine, total hip, or femoral neck based on local read of the DXA scans at month 48\n* Intolerance to zoledronic acid'}, 'identificationModule': {'nctId': 'NCT00896532', 'briefTitle': 'Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomised, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density', 'orgStudyIdInfo': {'id': '20060326'}, 'secondaryIdInfos': [{'id': '2008-005991-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously (SC) for up to 24 months.\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.', 'interventionNames': ['Drug: Placebo to Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab', 'Drug: Zoledronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alendronate', 'description': 'Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24).\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. At month 36 participants ended study participation.', 'interventionNames': ['Drug: Alendronate', 'Drug: Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teriparatide', 'description': 'Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation.', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 70 mg QM', 'description': 'Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months.\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.', 'interventionNames': ['Drug: Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab', 'Drug: Zoledronic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 140 mg Q3M', 'description': 'Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months.\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.', 'interventionNames': ['Drug: Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab', 'Drug: Zoledronic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 140 mg QM', 'description': 'Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months.\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.', 'interventionNames': ['Drug: Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab', 'Drug: Zoledronic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 210 mg Q3M', 'description': 'Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months.\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.', 'interventionNames': ['Drug: Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab', 'Drug: Zoledronic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 210 mg QM', 'description': 'Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months.\n\nParticipants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention.', 'interventionNames': ['Drug: Romosozumab', 'Drug: Denosumab', 'Drug: Placebo to Denosumab', 'Drug: Zoledronic acid']}], 'interventions': [{'name': 'Placebo to Romosozumab', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection QM or Q3M.', 'armGroupLabels': ['Placebo']}, {'name': 'Alendronate', 'type': 'DRUG', 'otherNames': ['Fosamax'], 'description': 'Administered orally once a week', 'armGroupLabels': ['Alendronate']}, {'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['Forsteo'], 'description': 'Teriparatide 20 μg administered by subcutaneous injection once a day', 'armGroupLabels': ['Teriparatide']}, {'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['AMG 785', 'EVENITY™'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Alendronate', 'Romosozumab 140 mg Q3M', 'Romosozumab 140 mg QM', 'Romosozumab 210 mg Q3M', 'Romosozumab 210 mg QM', 'Romosozumab 70 mg QM']}, {'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['Prolia®'], 'description': 'Denosumab 60 mg administered by subcutaneous injection Q6M', 'armGroupLabels': ['Alendronate', 'Placebo', 'Romosozumab 140 mg Q3M', 'Romosozumab 140 mg QM', 'Romosozumab 210 mg Q3M', 'Romosozumab 210 mg QM', 'Romosozumab 70 mg QM']}, {'name': 'Placebo to Denosumab', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection Q6M', 'armGroupLabels': ['Alendronate', 'Placebo', 'Romosozumab 140 mg Q3M', 'Romosozumab 140 mg QM', 'Romosozumab 210 mg Q3M', 'Romosozumab 210 mg QM', 'Romosozumab 70 mg QM']}, {'name': 'Zoledronic acid', 'type': 'DRUG', 'otherNames': ['Aclasta'], 'description': 'Zoledronic acid 5 mg administered intravenously', 'armGroupLabels': ['Placebo', 'Romosozumab 140 mg Q3M', 'Romosozumab 140 mg QM', 'Romosozumab 210 mg Q3M', 'Romosozumab 210 mg QM', 'Romosozumab 70 mg QM']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}