Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT03432533
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2018-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557282', 'term': 'romosozumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', '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': 'up to Month 9 (-7/+3 days)', 'description': 'All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Romosozumab 210 mg SC QM by PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC, QM by HCP administration with PFS.', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 48, 'seriousNumAtRisk': 141, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Romosozumab 210 mg SC QM by AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 64, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 141, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lumbar Spine BMD at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.'}, {'id': 'OG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Population: participants with lumbar spine BMD values at baseline and \\>=1 postbaseline visit at Month 6.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Hip BMD at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.'}, {'id': 'OG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change from baseline in BMD for total hip as measured by DXA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Population: participants with lumbar spine BMD values at baseline and \\>=1 postbaseline visit at Month 6.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Femoral Neck BMD at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.'}, {'id': 'OG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change from baseline in BMD at femoral neck as measured by DXA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Population: participants with lumbar spine BMD values at baseline and \\>=1 postbaseline visit at Month 6.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.'}, {'id': 'OG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.'}], 'classes': [{'title': 'TEAEs: All', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs: SAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs: Leading to Study Drug Discontinuation (DC)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs: Fatal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-Related (TR) TEAEs: All', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'TR TEAEs: SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TR TEAEs: Leading to Study Drug DC', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'TR TEAEs: Fatal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Device-Related (DR) TEAEs: All', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'DR TEAEs: SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DR TEAEs: Leading to Study Drug DC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'DR TEAEs: Fatal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Month 9 (-7/+3 days)', 'description': 'AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Number of Participants Developing Anti-Romosozumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.'}, {'id': 'OG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.'}], 'classes': [{'title': 'Binding Antibody Positive Post-BL', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Transient Binding Antibody Positive Post-BL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Neutralizing Antibody Positive Post-BL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Transient Neutralizing Antibody Positive Post-BL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Month 9 (-7/+3 days)', 'description': "Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all randomized participants who received at least 1 dose of study drug as well as baseline and postbaseline antibody results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab subcutaneously (SC) once a month (QM) by health care provider (HCP) administration with pre-filled syringe (PFS).'}, {'id': 'FG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with autoinjector (AI)/pen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'Completed 6-Month Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'comment': 'Completed 9-Month Study Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 36 centers in Poland, United Kingdom, and United States.', 'preAssignmentDetails': 'Participants were randomized in a 1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by HCP administration with PFS.'}, {'id': 'BG001', 'title': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants received 210 mg romosozumab SC QM by self-administration with AI/pen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.3', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '69.5', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lumbar Spine Bone Mineral Density (BMD) T-Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-2.69', 'spread': '1.03', 'groupId': 'BG000'}, {'value': '-2.85', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '-2.77', 'spread': '1.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The T-score is the BMD at the site when compared to that of a healthy thirty-year-old of the same sex. Lower scores (more negative) mean lower bone density. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5, meaning below-normal bone density without full osteoporosis; 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': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-2.29', 'spread': '0.73', 'groupId': 'BG000'}, {'value': '-2.30', 'spread': '0.77', 'groupId': 'BG001'}, {'value': '-2.29', 'spread': '0.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The T-score is the BMD at the site when compared to that of a healthy thirty-year-old of the same sex. Lower scores (more negative) mean lower bone density. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5, meaning below-normal bone density without full osteoporosis; 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': 'Femoral Neck BMD T-Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-2.54', 'spread': '0.63', 'groupId': 'BG000'}, {'value': '-2.49', 'spread': '0.65', 'groupId': 'BG001'}, {'value': '-2.52', 'spread': '0.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The T-score is the BMD at the site when compared to that of a healthy thirty-year-old of the same sex. Lower scores (more negative) mean lower bone density. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5, meaning below-normal bone density without full osteoporosis; 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': 'Participants With Pre-Existing Anti-Romosozumab Antibodies', 'classes': [{'title': 'Binding Antibody Positive at or Before BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Neutralizing Antibody Positive at or Before BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with pre-existing antibodies, including those who were binding antibody positive and those who were neutralizing antibody positive at or before baseline (BL).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with an assessment at baseline.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-10', 'size': 1797099, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-24T07:19', 'hasProtocol': True}, {'date': '2019-05-08', 'size': 741626, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-24T07:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study; blinding procedures are not applicable.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After signing the informed consent form (ICF), subjects will undergo the following periods:\n\n* Screening period (35 days) to complete eligibility assessments\n* Open-label treatment period (6 months)\n* Follow-up period (3 months) During the open-label treatment period, subjects will be randomized to receive romosozumab either via HCP administration with PFS or via self-administration withAI/Pen.\n\nDuring the follow-up period, subjects will be followed for an additional 3 months to ensure appropriate follow-up for anti-romosozumab antibody formation and adverse events.\n\nThe primary analysis will be performed after all subjects have had the opportunity to complete the Month 6 visit. The final analysis will be performed after all subjects have had the opportunity to complete the Month 9 visit.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2018-01-30', 'resultsFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-09', 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Lumbar Spine BMD at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Total Hip BMD at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change from baseline in BMD for total hip as measured by DXA.'}, {'measure': 'Percent Change From Baseline in Femoral Neck BMD at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change from baseline in BMD at femoral neck as measured by DXA.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths', 'timeFrame': 'up to Month 9 (-7/+3 days)', 'description': 'AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.'}, {'measure': 'Number of Participants Developing Anti-Romosozumab Antibodies', 'timeFrame': 'up to Month 9 (-7/+3 days)', 'description': "Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Post-Menopausal osteoporosis'], 'conditions': ['Post-Menopausal Osteoporosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has provided informed consent/assent prior to initiation of any studyspecific activities/procedures, or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.\n* Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening)\n\n -≥ 55 to ≤ 90 years of age at the time of informed consent\n* Ambulatory\n* BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans -Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee\n* Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator or designee\n* Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets at least 2 of the following clinical risk factors for fracture\n\n * ≥ 70 years of age at the time of informed consent\n * BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans\n * current smoker\n * consumption of ≥ 3 glasses of alcohol a day\n * parental history of fragility (ie, osteoporosis-related) fracture\n * body weight ≤ 125 pounds/56 kilogram\n* Ability to follow and understand instructions and the ability to self-inject, per investigator judgement\n\nExclusion Criteria:\n\n* History of osteonecrosis of the jaw and/or atypical femoral fracture\n* History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome\n* Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget's disease, sclerosteosis and osteopetrosis)\n* Vitamin D insufficiency \\[defined as serum 25 (OH) vitamin D levels \\< 20 ng/mL\\], as determined by the central laboratory. Vitamin D repletion will be permitted a nd subjects may be rescreened\n* Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by subject report or by chart review, per principal investigator evaluation\n* Current clinical hypothyroidism (unless well controlled on stable thyroid replacement therapy) by subject report or by chart review, per principal investigator evaluation normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent hypercalcemia; or PTH values \\> 20% above the upper limit of normal (ULN) in normocalcemic subjects.\n* Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the ULN as assessed by the central laboratory"}, 'identificationModule': {'nctId': 'NCT03432533', 'briefTitle': 'A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe', 'orgStudyIdInfo': {'id': '20150120'}, 'secondaryIdInfos': [{'id': '2017-003512-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Romosozumab 210 mg QM: PFS', 'description': 'During the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS.', 'interventionNames': ['Drug: romosozumab HCP administration with PFS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Romosozumab 210 mg QM: AI/Pen', 'description': 'During the open-label treatment period, participants receive 210 mg romosozumab SC QM by self-administration with AI/pen.', 'interventionNames': ['Device: romosozumab self-administration with AI/Pen']}], 'interventions': [{'name': 'romosozumab HCP administration with PFS', 'type': 'DRUG', 'otherNames': ['Evenity', 'AMG785'], 'description': '210 mg romosozumab SC QM by HCP administration with 2 PFS', 'armGroupLabels': ['Romosozumab 210 mg QM: PFS']}, {'name': 'romosozumab self-administration with AI/Pen', 'type': 'DEVICE', 'otherNames': ['Evenity', 'AMG785'], 'description': '210 mg romosozumab SC QM by self-administration with 2 AI/Pens', 'armGroupLabels': ['Romosozumab 210 mg QM: AI/Pen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 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'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'RM1 3PJ', 'city': 'Romford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'https://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}