Fragility Fractures, Osteopenia, Osteoporosis
Conditions
Keywords
Decision Aid, Shared Decision Making, Shared Medical Decision Making
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)
Interventions
BEHAVIORALFRAX + 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.
BEHAVIORALFRAX estimated fracture risk
The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX
Sponsors
Foundation for Informed Medical Decision Making
Olmsted Medical Center
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 90 Years
Healthy volunteers
Yes
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.
Exclusion criteria
* Unable to speak or read English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication start/stop, knowledge, and patient involvement. | Baseline and at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Decisional quality. | Baseline and at 6 months |
Countries
United States
Outcome results
None listed