- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285168
A Randomized Controlled Trial of a Bone Density Decision Aide
A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- physicians involved in referring patients for DXA bone density testing
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1 - Control
Usual Bone Density Report
|
|
2 - Intervention
Bone Density Report with Absolute 10-year Fracture Risk Decision Aide
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Absolute 10-year Fracture Risk Report
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William D Leslie, MD FRCPC, University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2003:099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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