A Randomized Controlled Trial of a Bone Density Decision Aide - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 30, 2006

Last Updated Date

January 29, 2009

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00285168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Randomized Controlled Trial of a Bone Density Decision Aide

Official Title ^†

A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis

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 Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Osteoporosis

Intervention ^†

Behavioral: Bone Density Decision Aide

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

200

Estimated Completion Date

March 2009

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

physicians involved in referring patients for DXA bone density testing

Exclusion Criteria:

none

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00285168

Responsible Party

WIlliam D. Leslie, principal investigator, University of Manitoba

Secondary IDs ^††

Study Sponsor ^†

University of Manitoba

Collaborators ^††

Investigators ^†

Principal Investigator:

William D Leslie, MD FRCPC

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.