Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT00960934
Status:
TERMINATED
Last Update Posted:
2015-02-18
First Post:
2009-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Norway', 'Russia', 'South Africa', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'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': 'C568849', 'term': 'JTT 305'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp and Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results of the study associated with their study site independently.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011', 'description': 'All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.', 'otherNumAtRisk': 64, 'otherNumAffected': 18, 'seriousNumAtRisk': 64, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.', 'otherNumAtRisk': 62, 'otherNumAffected': 24, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.', 'otherNumAtRisk': 64, 'otherNumAffected': 15, 'seriousNumAtRisk': 64, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.', 'otherNumAtRisk': 64, 'otherNumAffected': 28, 'seriousNumAtRisk': 64, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 18, 'seriousNumAtRisk': 63, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 26, 'seriousNumAtRisk': 63, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chest Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Common Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pain in Hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Angina pectoris aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'COPD exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis of leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'External haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fracture malunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gallbladder carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ischaemic heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paroxysmal atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Postural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '1.68'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.53', 'upperLimit': '2.48'}, {'value': '0.92', 'groupId': 'OG002', 'lowerLimit': '-0.02', 'upperLimit': '1.87'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '0.73', 'upperLimit': '2.64'}, {'value': '1.13', 'groupId': 'OG004', 'lowerLimit': '0.18', 'upperLimit': '2.08'}, {'value': '0.57', 'groupId': 'OG005', 'lowerLimit': '-0.40', 'upperLimit': '1.55'}]}]}], 'analyses': [{'pValue': '0.749', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '2.16', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.333', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '2.83', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.823', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '1.84', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.457', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '2.61', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.823', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '1.50', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (BL) and Month 6', 'description': 'Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}, {'value': '56.3', 'groupId': 'OG003'}, {'value': '73.0', 'groupId': 'OG004'}, {'value': '3.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '69.8', 'ciLowerLimit': '56.5', 'ciUpperLimit': '80.0', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.1', 'ciLowerLimit': '39.6', 'ciUpperLimit': '65.2', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.6', 'ciLowerLimit': '17.6', 'ciUpperLimit': '42.4', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.1', 'ciLowerLimit': '17.0', 'ciUpperLimit': '42.0', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.254', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '14.4', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 6', 'description': 'Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (\\>2.5 mmol/L).\n\nBased on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '2.96', 'upperLimit': '5.35'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '2.75', 'upperLimit': '5.09'}, {'value': '37.5', 'groupId': 'OG003', 'lowerLimit': '4.28', 'upperLimit': '6.69'}, {'value': '49.2', 'groupId': 'OG004', 'lowerLimit': '5.10', 'upperLimit': '7.50'}, {'value': '1.6', 'groupId': 'OG005', 'lowerLimit': '-1.04', 'upperLimit': '1.22'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.6', 'ciLowerLimit': '34.9', 'ciUpperLimit': '60.0', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.9', 'ciLowerLimit': '24.1', 'ciUpperLimit': '48.5', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.2', 'ciLowerLimit': '7.7', 'ciUpperLimit': '28.7', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.050', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '18.2', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '4.2', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 6', 'description': 'Albumin-Corrected Calcium = (\\[4 - plasma albumin in g/dL\\] × 0.8 + serum calcium).\n\n≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Kidney Stones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '5.8', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.999', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '5.7', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.999', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '5.7', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '8.6', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.321', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '8.4', 'groupDescription': 'The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.', 'statisticalMethod': 'Miettinen and Nurminen Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 6', 'description': 'Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Bone Neoplasms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Month 6', 'description': 'Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.95', 'upperLimit': '0.55'}, {'value': '-0.32', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '0.46'}, {'value': '0.32', 'groupId': 'OG002', 'lowerLimit': '-0.43', 'upperLimit': '1.07'}, {'value': '0.07', 'groupId': 'OG003', 'lowerLimit': '-0.69', 'upperLimit': '0.82'}, {'value': '0.33', 'groupId': 'OG004', 'lowerLimit': '-0.43', 'upperLimit': '1.08'}, {'value': '0.08', 'groupId': 'OG005', 'lowerLimit': '-0.69', 'upperLimit': '0.86'}]}]}], 'analyses': [{'pValue': '0.959', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '1.51', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.971', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '1.04', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.959', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '1.42', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.915', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '0.97', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.959', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-1.60', 'ciUpperLimit': '1.04', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '2.25'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-1.58', 'upperLimit': '0.54'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '-0.89', 'upperLimit': '1.14'}, {'value': '-0.20', 'groupId': 'OG003', 'lowerLimit': '-1.23', 'upperLimit': '0.83'}, {'value': '0.54', 'groupId': 'OG004', 'lowerLimit': '-0.48', 'upperLimit': '1.56'}, {'value': '-0.04', 'groupId': 'OG005', 'lowerLimit': '-1.09', 'upperLimit': '1.01'}]}]}], 'analyses': [{'pValue': '0.849', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '2.37', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.964', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '1.47', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.964', 'groupIds': ['OG002'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '1.59', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.855', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '1.27', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.287', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '3.12', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': '-0.78', 'upperLimit': '1.60'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '2.19'}, {'value': '0.54', 'groupId': 'OG002', 'lowerLimit': '-0.65', 'upperLimit': '1.74'}, {'value': '0.49', 'groupId': 'OG003', 'lowerLimit': '-0.72', 'upperLimit': '1.70'}, {'value': '1.10', 'groupId': 'OG004', 'lowerLimit': '-0.11', 'upperLimit': '2.30'}, {'value': '0.49', 'groupId': 'OG005', 'lowerLimit': '-0.74', 'upperLimit': '1.73'}]}]}], 'analyses': [{'pValue': '0.933', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '2.77', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.999', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '1.68', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.999', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '1.93', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.959', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '2.57', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.999', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-2.10', 'ciUpperLimit': '1.94', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.97'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '-0.28', 'upperLimit': '0.84'}, {'value': '0.80', 'groupId': 'OG002', 'lowerLimit': '0.27', 'upperLimit': '1.33'}, {'value': '0.21', 'groupId': 'OG003', 'lowerLimit': '-0.35', 'upperLimit': '0.76'}, {'value': '0.09', 'groupId': 'OG004', 'lowerLimit': '-0.44', 'upperLimit': '0.63'}, {'value': '0.27', 'groupId': 'OG005', 'lowerLimit': '-0.29', 'upperLimit': '0.82'}]}]}], 'analyses': [{'pValue': '0.976', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.77', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.982', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.80', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.489', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '1.49', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.982', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.78', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.976', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '1.08', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-1.42', 'upperLimit': '0.48'}, {'value': '-0.32', 'groupId': 'OG001', 'lowerLimit': '-1.30', 'upperLimit': '0.65'}, {'value': '0.44', 'groupId': 'OG002', 'lowerLimit': '-0.47', 'upperLimit': '1.36'}, {'value': '-0.49', 'groupId': 'OG003', 'lowerLimit': '-1.46', 'upperLimit': '0.48'}, {'value': '-0.56', 'groupId': 'OG004', 'lowerLimit': '-1.50', 'upperLimit': '0.37'}, {'value': '-0.21', 'groupId': 'OG005', 'lowerLimit': '-1.18', 'upperLimit': '0.76'}]}]}], 'analyses': [{'pValue': '0.961', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-2.00', 'ciUpperLimit': '1.31', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.961', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '1.34', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.778', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '2.33', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.961', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '1.24', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.961', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '1.26', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.41', 'groupId': 'OG000', 'lowerLimit': '-1.44', 'upperLimit': '0.62'}, {'value': '-0.34', 'groupId': 'OG001', 'lowerLimit': '-1.43', 'upperLimit': '0.75'}, {'value': '-0.89', 'groupId': 'OG002', 'lowerLimit': '-1.90', 'upperLimit': '0.13'}, {'value': '-0.88', 'groupId': 'OG003', 'lowerLimit': '-1.97', 'upperLimit': '0.22'}, {'value': '-0.80', 'groupId': 'OG004', 'lowerLimit': '-1.87', 'upperLimit': '0.26'}, {'value': '-0.37', 'groupId': 'OG005', 'lowerLimit': '-1.37', 'upperLimit': '0.63'}]}]}], 'analyses': [{'pValue': '0.901', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-2.03', 'ciUpperLimit': '1.17', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.901', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '1.17', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.901', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '1.13', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.997', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '1.35', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.997', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '1.43', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '3.75'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '-0.97', 'upperLimit': '2.85'}, {'value': '1.83', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '3.64'}, {'value': '3.35', 'groupId': 'OG003', 'lowerLimit': '1.43', 'upperLimit': '5.27'}, {'value': '1.06', 'groupId': 'OG004', 'lowerLimit': '-0.83', 'upperLimit': '2.96'}, {'value': '1.43', 'groupId': 'OG005', 'lowerLimit': '-0.33', 'upperLimit': '3.19'}]}]}], 'analyses': [{'pValue': '0.979', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-2.73', 'ciUpperLimit': '1.99', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.363', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '4.95', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.979', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '2.98', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.979', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '2.30', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.979', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-2.34', 'ciUpperLimit': '3.37', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine 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placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.18', 'groupId': 'OG000', 'lowerLimit': '-21.23', 'upperLimit': '-2.10'}, {'value': '-9.46', 'groupId': 'OG001', 'lowerLimit': '-18.87', 'upperLimit': '1.03'}, {'value': '-20.73', 'groupId': 'OG002', 'lowerLimit': '-28.79', 'upperLimit': '-11.76'}, {'value': '-7.82', 'groupId': 'OG003', 'lowerLimit': '-17.33', 'upperLimit': '2.78'}, {'value': '1.87', 'groupId': 'OG004', 'lowerLimit': '-8.53', 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'ciPctValue': '95', 'paramValue': '6.31', 'ciLowerLimit': '-3.81', 'ciUpperLimit': '16.45', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.283', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.46', 'ciLowerLimit': '-3.39', 'ciUpperLimit': '14.31', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 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2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.61', 'groupId': 'OG000', 'lowerLimit': '-18.19', 'upperLimit': '-4.50'}, {'value': '-2.75', 'groupId': 'OG001', 'lowerLimit': '-10.10', 'upperLimit': '5.19'}, {'value': '9.18', 'groupId': 'OG002', 'lowerLimit': '1.15', 'upperLimit': '17.86'}, {'value': '25.79', 'groupId': 'OG003', 'lowerLimit': '16.45', 'upperLimit': '35.88'}, {'value': '37.43', 'groupId': 'OG004', 'lowerLimit': '27.24', 'upperLimit': '48.42'}, {'value': '-15.62', 'groupId': 'OG005', 'lowerLimit': '-21.83', 'upperLimit': '-8.92'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.05', 'ciLowerLimit': '37.83', 'ciUpperLimit': '68.53', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.41', 'ciLowerLimit': '27.36', 'ciUpperLimit': '55.65', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.81', 'ciLowerLimit': '12.39', 'ciUpperLimit': '37.33', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.87', 'ciLowerLimit': '1.73', 'ciUpperLimit': '24.06', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.397', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LS Mean Difference in Change From BL', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.02', 'ciLowerLimit': '-5.31', 'ciUpperLimit': '13.36', 'pValueComment': "The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.", 'statisticalMethod': 'Longitudinal Data Analysis Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'FG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'FG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'FG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'FG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '64'}, {'groupId': 'FG005', 'numSubjects': '64'}]}, {'type': 'Number Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'comment': '1 participant was randomized but not treated', 'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'comment': '1 participant was randomized but not treated', 'groupId': 'FG004', 'numSubjects': '63'}, {'comment': '1 participant was randomized but not treated', 'groupId': 'FG005', 'numSubjects': '63'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '64'}, {'groupId': 'FG005', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '50'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '49'}]}]}], 'preAssignmentDetails': '383 participants were randomized on study and 380 participants were treated on study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'BG001', 'title': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'BG002', 'title': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'BG003', 'title': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'BG004', 'title': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '6.0', 'groupId': 'BG002'}, {'value': '67.8', 'spread': '6.4', 'groupId': 'BG003'}, {'value': '66.5', 'spread': '5.4', 'groupId': 'BG004'}, {'value': '67.6', 'spread': '6.7', 'groupId': 'BG005'}, {'value': '67.2', 'spread': '6.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-01', 'studyFirstSubmitDate': '2009-08-17', 'resultsFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-02', 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)', 'timeFrame': 'Baseline (BL) and Month 6', 'description': 'Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).'}, {'measure': 'Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change', 'timeFrame': 'Baseline through Month 6', 'description': 'Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (\\>2.5 mmol/L).\n\nBased on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.'}, {'measure': 'Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change', 'timeFrame': 'Baseline through Month 6', 'description': 'Albumin-Corrected Calcium = (\\[4 - plasma albumin in g/dL\\] × 0.8 + serum calcium).\n\n≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.'}, {'measure': 'Percentage of Participants With Kidney Stones', 'timeFrame': 'Baseline through Month 6', 'description': 'Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.'}, {'measure': 'Percentage of Participants With Bone Neoplasms', 'timeFrame': 'Baseline through Month 6', 'description': 'Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.'}], 'secondaryOutcomes': [{'measure': 'LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD', 'timeFrame': 'Baseline and Month 6', 'description': 'DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\\^2).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip', 'timeFrame': 'Baseline and Month 6', 'description': 'Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine', 'timeFrame': 'Baseline and Month 6', 'description': 'Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)', 'timeFrame': 'Baseline and Month 6', 'description': 'The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)', 'timeFrame': 'Baseline to Month 6', 'description': 'C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)', 'timeFrame': 'Baseline and Month 6', 'description': 'Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)', 'timeFrame': 'Baseline to Month 6', 'description': 'Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.'}, {'measure': 'LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin', 'timeFrame': 'Baseline and Month 6', 'description': 'Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Postmenopausal', 'MK-5442'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '25166719', 'type': 'RESULT', 'citation': 'Halse J, Greenspan S, Cosman F, Ellis G, Santora A, Leung A, Heyden N, Samanta S, Doleckyj S, Rosenberg E, Denker AE. A phase 2, randomized, placebo-controlled, dose-ranging study of the calcium-sensing receptor antagonist MK-5442 in the treatment of postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2014 Nov;99(11):E2207-15. doi: 10.1210/jc.2013-4009. Epub 2014 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to identify an appropriate dose of\n\nMK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.', 'detailedDescription': 'Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal for at least 5 years\n* No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy\n* Agrees not to use medications for osteoporosis except medications associated with the study\n* Areal bone mineral density (BMD) T-score \\<-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of \\< -3.5\n\nExclusion Criteria:\n\n* Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight \\>250 lbs)\n* Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months\n* Use of intravenous bisphosphonates, strontium, or growth hormone at any time\n* Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1\n* Use of pioglitazone or rosiglitazone at study screening\n* Use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to Study Visit 1\n* Prior total thyroidectomy\n* Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome (AIDS)-related illness\n* History of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers\n* History of Paget's disease and/or kidney stones\n* An active user of any illicit drug\n* History of or active alcohol abuse\n* Participated in an investigational drug study within the past 30 days"}, 'identificationModule': {'nctId': 'NCT00960934', 'briefTitle': 'A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': '5442-001'}, 'secondaryIdInfos': [{'id': '2009-012926-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-5442 2.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.', 'interventionNames': ['Drug: MK-5442', 'Drug: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'MK-5442 5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.', 'interventionNames': ['Drug: MK-5442', 'Drug: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'MK-5442 7.5 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.', 'interventionNames': ['Drug: MK-5442', 'Drug: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'MK-5442 10 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.', 'interventionNames': ['Drug: MK-5442', 'Drug: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'MK-5442 15 mg', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.', 'interventionNames': ['Drug: MK-5442', 'Drug: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.', 'interventionNames': ['Drug: Placebo', 'Dietary Supplement: Vitamin D3', 'Dietary Supplement: Calcium carbonate']}], 'interventions': [{'name': 'MK-5442', 'type': 'DRUG', 'description': 'MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.', 'armGroupLabels': ['MK-5442 10 mg', 'MK-5442 15 mg', 'MK-5442 2.5 mg', 'MK-5442 5 mg', 'MK-5442 7.5 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose-matched oral placebo to MK-5442', 'armGroupLabels': ['MK-5442 10 mg', 'MK-5442 15 mg', 'MK-5442 2.5 mg', 'MK-5442 5 mg', 'MK-5442 7.5 mg', 'Placebo']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D3, two 400 IU tablets daily throughout the study.', 'armGroupLabels': ['MK-5442 10 mg', 'MK-5442 15 mg', 'MK-5442 2.5 mg', 'MK-5442 5 mg', 'MK-5442 7.5 mg', 'Placebo']}, {'name': 'Calcium carbonate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.', 'armGroupLabels': ['MK-5442 10 mg', 'MK-5442 15 mg', 'MK-5442 2.5 mg', 'MK-5442 5 mg', 'MK-5442 7.5 mg', 'Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}