A Randomized Controlled Trial of a Bone Density Decision Aide

Terminated

• Conditions: Osteoporosis
• Interventions: Behavioral: Bone Density Decision Aide

• Registration Number: NCT00285168
• Lead Sponsor: University of Manitoba

Brief Summary

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

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-02-01
• Primary Completion: 2008-03
• Study Completion: 2010-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• physicians involved in referring patients for DXA bone density testing

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 - Intervention	Bone Density Decision Aide	Bone Density Report with Absolute 10-year Fracture Risk Decision Aide

Trial Locations

Locations (1)

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada