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A Randomized Controlled Trial of a Bone Density Decision Aide

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Information provided by (Responsible Party):
William D. Leslie, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00285168
First received: January 30, 2006
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoporosis
 Behavioral: Bone Density Decision Aide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Controlled Trial of a Bone Density Decision Aide in the Pharmacological Management of Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Enrollment: 200
Study Start Date: May 2005
Study Completion Date: March 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 - Control
Usual Bone Density Report
2 - Intervention
Bone Density Report with Absolute 10-year Fracture Risk Decision Aide
 Behavioral: Bone Density Decision Aide
Absolute 10-year Fracture Risk Report

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of physicians involved in referring patients for DXA bone density testing

Criteria

Inclusion Criteria:

  • physicians involved in referring patients for DXA bone density testing

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285168

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: William D Leslie, MD FRCPC University of Manitoba
  More Information

Additional Information:
Province of Manitoba BMD Program  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: William D. Leslie, Professor of Medicine and Radiology, University of Manitoba
ClinicalTrials.gov Identifier: NCT00285168     History of Changes
Other Study ID Numbers: H2003:099
Study First Received: January 30, 2006
Last Updated: July 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Osteoporosis
Fractures, Bone
Bone Mineral Density

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013