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Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians

This study has been completed.
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Olmsted Medical Center
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00949611
First received: July 28, 2009
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. FRAX (Fracture Risk Assessment Tool) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

  • FRAX
  • FRAX + decision aid
  • Usual care (no decision aid and no FRAX given to clinician)

Condition Intervention
Osteoporosis
Osteopenia
Fragility Fractures
 Behavioral: FRAX + Decision Aid
Behavioral: FRAX estimated fracture risk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Wiser Choices In Osteoporosis Choice II

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Medication start/stop, knowledge, and patient involvement. [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decisional quality. [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: May 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FRAX + Decision Aid Behavioral: FRAX + Decision Aid
Clinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications.
Other Name: Decision Support
No Intervention: Usual care
Experimental: FRAX estimated fracture risk Behavioral: FRAX estimated fracture risk
The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX
Other Name: Risk estimate

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
  • BMD T-Score < 1.0
  • Have appointment with clinician to discuss test results and treatment options
  • Patients with FRAX <20% risk who have taken a bisphosphonate for < 5 years.

Exclusion Criteria:

  • Unable to speak or read English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949611

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Foundation for Informed Medical Decision Making
Olmsted Medical Center
Investigators
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Victor Montori, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00949611     History of Changes
Other Study ID Numbers: 08-006070
Study First Received: July 28, 2009
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Decision Aid
Shared Decision Making
Shared Medical Decision Making

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

ClinicalTrials.gov processed this record on May 21, 2013