A Randomized Controlled Trial of a Bone Density Decision Aide

University of Manitoba

Status: Terminated

Conditions: Osteoporosis

Treatments: Behavioral: Bone Density Decision Aide

Study type: Observational

Funder types: Other

Identifiers

NCT00285168

H2003:099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• physicians involved in referring patients for DXA bone density testing

Exclusion criteria

• none

Trial design

200 participants in 2 patient groups

1 - Control

Description:

Usual Bone Density Report

2 - Intervention

Description:

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

Treatment:

Behavioral: Bone Density Decision Aide