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Sponsored by: |
University of Manitoba |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00285168 |
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.
Condition | Intervention |
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Osteoporosis |
Behavioral: Bone Density Decision Aide |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis |
Estimated Enrollment: | 200 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 - Control
Usual Bone Density Report
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2 - Intervention
Bone Density Report with Absolute 10-year Fracture Risk Decision Aide
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Behavioral: Bone Density Decision Aide
Absolute 10-year Fracture Risk Report
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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.
To 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients of physicians involved in referring patients for DXA bone density testing
Inclusion Criteria:
Exclusion Criteria:
Canada, Manitoba | |
St. Boniface General Hospital | |
Winnipeg, Manitoba, Canada, R2H 2A6 |
Principal Investigator: | William D Leslie, MD FRCPC | University of Manitoba |
Responsible Party: | University of Manitoba ( WIlliam D. Leslie, principal investigator ) |
Study ID Numbers: | H2003:099 |
Study First Received: | January 30, 2006 |
Last Updated: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00285168 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Osteoporosis Fractures, Bone Bone Mineral Density |
Musculoskeletal Diseases Fractures, Bone Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |