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A Randomized Controlled Trial of a Bone Density Decision Aide

NCT ID: NCT00285168

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis

Keywords

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Osteoporosis Fractures, Bone Bone Mineral Density

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 - Control

Usual Bone Density Report

No interventions assigned to this group

2 - Intervention

Bone Density Report with Absolute 10-year Fracture Risk Decision Aide

Bone Density Decision Aide

Intervention Type BEHAVIORAL

Absolute 10-year Fracture Risk Report

Interventions

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Bone Density Decision Aide

Absolute 10-year Fracture Risk Report

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* physicians involved in referring patients for DXA bone density testing

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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William D. Leslie

Professor of Medicine and Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William D Leslie, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Related Links

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http://www.gov.mb.ca/health/bonedensity/index.html

Province of Manitoba BMD Program

Other Identifiers

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H2003:099

Identifier Type: -

Identifier Source: org_study_id