Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-05 @ 5:46 PM
Study NCT ID:
NCT02422069
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Use of various PMO treatment modalities', 'timeFrame': 'Up to 12 months'}]}, 'conditionsModule': {'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll gynecology outpatients in Pakistan who meet eligibility criteria for observation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women\n* Age 50 years or greater\n\nExclusion Criteria:\n\n* Previously diagnosed osteoporosis, or receiving treatment for osteoporosis'}, 'identificationModule': {'nctId': 'NCT02422069', 'briefTitle': 'Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Registry on Post Menopausal Osteoporosis in Gynecology Setting in Pakistan (REPOSE)', 'orgStudyIdInfo': {'id': 'ML25212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Population', 'description': 'Gynecology outpatients who meet eligibility criteria will be enrolled and evaluated for the presence of PMO at screening. Women diagnosed with PMO will complete an additional visit to document the prescribed management plan.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'country': 'Pakistan', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '74700', 'city': 'Karachi', 'country': 'Pakistan', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74800', 'city': 'Karachi', 'country': 'Pakistan', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Karachi', 'country': 'Pakistan', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '20021', 'city': 'Lahore', 'country': 'Pakistan', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54550', 'city': 'Lahore', 'country': 'Pakistan', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Lahore', 'country': 'Pakistan', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Rawalpindi', 'country': 'Pakistan', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}