Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-03-24 @ 6:17 PM
Study NCT ID:
NCT00285168
Status:
TERMINATED
Last Update Posted:
2012-07-20
First Post:
2006-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of a Bone Density Decision Aide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'whyStopped': 'Inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2006-01-30', 'studyFirstSubmitQcDate': '2006-01-30', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Fractures, Bone', 'Bone Mineral Density'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gov.mb.ca/health/bonedensity/index.html', 'label': 'Province of Manitoba BMD Program'}]}, 'descriptionModule': {'briefSummary': 'This research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis.', 'detailedDescription': 'This observational research study is being conducted to determine if a modified bone mineral density (BMD) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. It is hypothesized that this supplementary information, provided in addition to the conventional BMD report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis. Physicians who only receive the conventional BMD reports without the supplemental information will be the control group.\n\nTo compare the rates of pharmacological interventions for osteoporosis in post-menopausal women, family / primary care physicians are randomized to receive either:(i) a conventional BMD report (absolute bone density, T-score result, Z-score result, qualitative statement indicating the BMD results classification of risk for fracture from osteoporosis according to the World Health Organization (WHO) criteria) versus (ii) a conventional BMD report plus a supplemental information sheet (all the information contained in the conventional BMD report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the WHO criteria - the number needed to treat (in person years) to prevent one fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of physicians involved in referring patients for DXA bone density testing', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physicians involved in referring patients for DXA bone density testing\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00285168', 'briefTitle': 'A Randomized Controlled Trial of a Bone Density Decision Aide', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis', 'orgStudyIdInfo': {'id': 'H2003:099'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 - Control', 'description': 'Usual Bone Density Report'}, {'label': '2 - Intervention', 'description': 'Bone Density Report with Absolute 10-year Fracture Risk Decision Aide', 'interventionNames': ['Behavioral: Bone Density Decision Aide']}], 'interventions': [{'name': 'Bone Density Decision Aide', 'type': 'BEHAVIORAL', 'description': 'Absolute 10-year Fracture Risk Report', 'armGroupLabels': ['2 - Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St. Boniface General Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'William D Leslie, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Radiology', 'investigatorFullName': 'William D. Leslie', 'investigatorAffiliation': 'University of Manitoba'}}}}