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

Study Overview
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Brief Summary
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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)

Official Title
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Wiser Choices In Osteoporosis Choice II

Conditions
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Osteoporosis, Osteopenia, Fragility Fractures

Intervention / Treatment
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* Behavioral: FRAX + Decision Aid
* Behavioral: FRAX estimated fracture risk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FRAX + Decision Aid<br> | Behavioral: FRAX + Decision Aid<br>* 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.<br>* Other names: Decision Support;|
| No Intervention: Usual care<br> | |
| Experimental: FRAX estimated fracture risk<br> | Behavioral: FRAX estimated fracture risk<br>* The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX<br>* Other names: Risk estimate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication start/stop, knowledge, and patient involvement. |  | Baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional quality. |  | Baseline and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Aid, Shared Decision Making, Shared Medical Decision Making