Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians
Not Applicable
Completed
- Conditions
- OsteoporosisOsteopeniaFragility Fractures
- Interventions
- Behavioral: FRAX + Decision AidBehavioral: FRAX estimated fracture risk
- Registration Number
- NCT00949611
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 79
Inclusion Criteria
- Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
- Bone mineral density (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.
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Exclusion Criteria
- Unable to speak or read English
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FRAX + Decision Aid FRAX + Decision Aid - FRAX estimated fracture risk FRAX estimated fracture risk -
- Primary Outcome Measures
Name Time Method Medication start/stop, knowledge, and patient involvement. Baseline and at 6 months
- Secondary Outcome Measures
Name Time Method Decisional quality. Baseline and at 6 months
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States