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

July 28, 2009
February 8, 2012
May 2009
February 2011   (final data collection date for primary outcome measure)
Medication start/stop, knowledge, and patient involvement. [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00949611 on ClinicalTrials.gov Archive Site
Decisional quality. [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians
Wiser Choices In Osteoporosis Choice II

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)
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Osteoporosis
  • Osteopenia
  • Fragility Fractures
  • 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
  • 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
  • Experimental: FRAX + Decision Aid
    Intervention: Behavioral: FRAX + Decision Aid
  • No Intervention: Usual care
  • Experimental: FRAX estimated fracture risk
    Intervention: Behavioral: FRAX estimated fracture risk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Female
50 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00949611
08-006070
No
Victor Montori, Mayo Clinic
Mayo Clinic
  • Foundation for Informed Medical Decision Making
  • Olmsted Medical Center
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
Mayo Clinic
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP