Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01221727
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2010-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'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': 'D000069448', 'term': 'Denosumab'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '47 days', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Midazolam With Denosumab Group With Midazolam 2mg on Day 1', 'otherNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15', 'otherNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Midazolam With Denosumab Group With Midazolam 2mg on Day 16', 'otherNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Midazolam Only Group With Midazolam 2mg on Day 1', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Midazolam Only Group With Midazolam 2mg on Day 2-15', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Midazolam Only Group With Midazolam 2mg on Day 16', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'unitless', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'title': 'AUC (0-t)', 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.29'}]}]}, {'title': 'AUC (0-inf)', 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.31'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.', 'unitOfMeasure': 'unitless', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'unitless', 'denomUnitsSelected': 'unitless', 'populationDescription': 'The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Ratio of PK AUC Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'unitless', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam Only', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16'}], 'classes': [{'title': 'AUC (0-t)', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.15'}]}]}, {'title': 'AUC (0-inf)', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.15'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.', 'unitOfMeasure': 'unitless', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'unitless', 'denomUnitsSelected': 'unitless', 'populationDescription': 'The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'PRIMARY', 'title': 'Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam With Denosumab Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'area', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16 , and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'title': 'AUC (0-t) Subject: Inter-subject', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.079', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-t) Residual: Intra-subject', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.025', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-inf) Subject: Inter-subject', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.085', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-inf) Residual: Intra-subject', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.027', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'area', 'denomUnitsSelected': 'area', 'populationDescription': 'The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'PRIMARY', 'title': 'Estimates of Inter- and Intra-subject Variability for PK Maximum Observed Plasma Concentration (Cmax) Parameter for Midazolam With Denosumab Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'concentration', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'title': 'Cmax Subject: Inter-subject', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.064', 'groupId': 'OG000'}]}]}, {'title': 'Cmax Residual: Intra-subject', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.023', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'concentration', 'denomUnitsSelected': 'concentration', 'populationDescription': 'The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam Only Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'area', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam Only', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16'}], 'classes': [{'title': 'AUC (0-t) Subject: Inter-subject', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.155', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-t) Residual: Intra-subject', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.016', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-inf) Subject: Inter-subject', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.175', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-inf) Residual: Intra-subject', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.015', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'area', 'denomUnitsSelected': 'area', 'populationDescription': 'The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Estimates of Inter- and Intra-subject Variability for PK Cmax Parameter for Midazolam Only Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'concentration', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam Only', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16'}], 'classes': [{'title': 'Cmax Subject: Inter-subject', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.143', 'groupId': 'OG000'}]}]}, {'title': 'Cmax Residual: Intra-subject', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.035', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'concentration', 'denomUnitsSelected': 'concentration', 'populationDescription': 'The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Summary of Serum Denosumab Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'concentration', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'title': 'Day 2 (Pre-dose)', 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'All the pre-dose concentration measurements are below LLOQ, and were treated as 0 in the analysis. Therefore, the true standard deviation is not able to be calculated.', 'groupId': 'OG000'}]}]}, {'title': 'Day 16 (0hr)', 'categories': [{'measurements': [{'value': '5820', 'spread': '1800', 'groupId': 'OG000'}]}]}, {'title': 'Day 17 (24hr)', 'categories': [{'measurements': [{'value': '5500', 'spread': '1940', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (day 2 pre-dose) to day 16', 'description': 'This table summarizes serum Denosumab for Midazolam with Denosumab group. The Lower Limit Of Quantification (LLOQ) is 20 ng/mL. On Day 2 (pre-dose), the true value is below LLOQ, and is treated as 0 in the analysis.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'concentration', 'denomUnitsSelected': 'concentration', 'populationDescription': 'Serum Denosumab will be collected for subjects in Midazolam with Denosumab group only. The analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum Denosumab concentrations are determinable when assessed.'}, {'type': 'SECONDARY', 'title': 'Summary of Serum C-Telopeptide Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'concentration', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'title': 'Baseline (day 2 pre-dose)', 'categories': [{'measurements': [{'value': '0.4655', 'spread': '0.0698', 'groupId': 'OG000', 'lowerLimit': '0.3390', 'upperLimit': '0.6290'}]}]}, {'title': 'Day 16', 'categories': [{'measurements': [{'value': '0.0606', 'spread': '0.0030', 'groupId': 'OG000', 'lowerLimit': '0.0483', 'upperLimit': '0.0662'}]}]}, {'title': 'Change from baseline to Day 16', 'categories': [{'measurements': [{'value': '-0.4079', 'spread': '0.0702', 'groupId': 'OG000', 'lowerLimit': '-0.5752', 'upperLimit': '-0.2712'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (day 2 pre-dose) to day 16', 'description': 'This table summarizes serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'concentration', 'denomUnitsSelected': 'concentration', 'populationDescription': 'Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.'}, {'type': 'PRIMARY', 'title': 'Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'unitless', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.29'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.', 'unitOfMeasure': 'unitless', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'unitless', 'denomUnitsSelected': 'unitless', 'populationDescription': 'The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}, {'type': 'SECONDARY', 'title': 'Summary of Percent Change From Baseline to Day 16 for Serum C-Telopeptide Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'percentage', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam With Denosumab', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2'}], 'classes': [{'categories': [{'measurements': [{'value': '-87.52', 'groupId': 'OG000', 'lowerLimit': '-91.45', 'upperLimit': '-80.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (day 2 pre-dose) to day 16', 'description': 'This table summarizes percent change from baseline to day 16 for serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'percentage', 'denomUnitsSelected': 'percentage', 'populationDescription': 'Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.'}, {'type': 'SECONDARY', 'title': 'Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'unitless', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam Only', 'description': 'Subjects received 2 mg oral dose of Midazolam on day 1 and day 16'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.33'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.', 'unitOfMeasure': 'unitless', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'unitless', 'denomUnitsSelected': 'unitless', 'populationDescription': 'The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midazolam With Denosumab', 'description': '2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2'}, {'id': 'FG001', 'title': 'Midazolam Only', 'description': '2 mg oral dose of Midazolam on Day 1 and Day 16.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of subjects randomized into the study', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'Number of subjects randomized into the study', 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Number of subjects received investigational product', 'groupId': 'FG000', 'numSubjects': '19'}, {'comment': 'Number of subjects received investigational product', 'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Midazolam With Denosumab', 'description': '2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2. Out of 21 subjects enrolled and randomized, 19 subjects received investigation product.'}, {'id': 'BG001', 'title': 'Midazolam Only', 'description': '2 mg oral dose of Midazolam on Day 1 and Day 16. Out of 9 subjects enrolled and randomized, 8 subjects received investigation product.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.42', 'spread': '6.16', 'groupId': 'BG000'}, {'value': '66.25', 'spread': '5.34', 'groupId': 'BG001'}, {'value': '64.96', 'spread': '5.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '>=65 years and <75 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', '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': [{'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': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '23', '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2010-10-14', 'resultsFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2010-10-14', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-05', 'studyFirstPostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.'}, {'measure': 'Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam With Denosumab Group', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability'}, {'measure': 'Estimates of Inter- and Intra-subject Variability for PK Maximum Observed Plasma Concentration (Cmax) Parameter for Midazolam With Denosumab Group', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability'}, {'measure': 'Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.'}], 'secondaryOutcomes': [{'measure': 'Ratio of PK AUC Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.'}, {'measure': 'Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam Only Group', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability.'}, {'measure': 'Estimates of Inter- and Intra-subject Variability for PK Cmax Parameter for Midazolam Only Group', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability.'}, {'measure': 'Summary of Serum Denosumab Concentration', 'timeFrame': 'Baseline (day 2 pre-dose) to day 16', 'description': 'This table summarizes serum Denosumab for Midazolam with Denosumab group. The Lower Limit Of Quantification (LLOQ) is 20 ng/mL. On Day 2 (pre-dose), the true value is below LLOQ, and is treated as 0 in the analysis.'}, {'measure': 'Summary of Serum C-Telopeptide Concentration', 'timeFrame': 'Baseline (day 2 pre-dose) to day 16', 'description': 'This table summarizes serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.'}, {'measure': 'Summary of Percent Change From Baseline to Day 16 for Serum C-Telopeptide Concentration', 'timeFrame': 'Baseline (day 2 pre-dose) to day 16', 'description': 'This table summarizes percent change from baseline to day 16 for serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.'}, {'measure': 'Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)', 'timeFrame': 'From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose', 'description': 'The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amgen', 'Phase 1', 'Postmenopausal', 'Osteoporosis'], 'conditions': ['Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '25505582', 'type': 'BACKGROUND', 'citation': 'Jang G, Kaufman A, Lee E, Hamilton L, Hutton S, Egbuna O, Padhi D. A clinical therapeutic protein drug-drug interaction study: coadministration of denosumab and midazolam in postmenopausal women with osteoporosis. Pharmacol Res Perspect. 2014 Apr;2(2):e00033. doi: 10.1002/prp2.33. Epub 2014 Mar 13.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.', 'detailedDescription': 'Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the abdomen. On study day 16, another 2 mg oral dose of midazolam will be administered to all subjects (Groups A and B) followed by a 24 hour PK collection. The primary analysis to determine the effect of denosumab on the PK of midazolam will be based on data from subjects in Group A only.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between 45 to 75 years of age\n* Postmenopausal women\n* Osteoporosis\n\nExclusion Criteria:\n\n* Use of any known inhibitors of cytochrome P450 3A4/P-gp (CYP3A4) within 14 days or 5 half lives, whichever is longer; or grapefruit juice or grapefruit containing products within 7 days prior to investigational product administration\n* Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer, prior to investigational product administration\n* Use of any herbal medicine with a known impact on CYP3A4 (eg, St. John's wort) within 30 days prior to investigational product administration\n* Current use of medications prescribed for osteoporosis treatment\n* Use of midazolam within 14 days prior to investigational product administration\n* Influenza or other vaccination within 28 days of screening\n* Previous exposure to denosumab"}, 'identificationModule': {'nctId': 'NCT01221727', 'briefTitle': 'The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam, a Cytochrome P450 3A4/P-gp (CYP3A4) Substrate, in Postmenopausal Osteoporotic Women', 'orgStudyIdInfo': {'id': '20101131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Midazolam', 'description': 'All 27 subjects will receive midazolam.', 'interventionNames': ['Drug: Denosumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab', 'description': 'Eighteen (18) subjects will receive denosumab.', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['AMG 162'], 'description': 'Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.', 'armGroupLabels': ['Midazolam']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'All subjects will receive two oral dose administrations of midazolam.', 'armGroupLabels': ['Denosumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}