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

Mayo Clinic

Status: Completed

Conditions: Osteopenia; Osteoporosis; Fragility Fractures

Treatments: Behavioral: FRAX estimated fracture risk; Behavioral: FRAX + Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT00949611

08-006070

Details and patient eligibility

About

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)

Enrollment: 79 patients

Sex: Female

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 3 patient groups

FRAX + Decision Aid

Experimental group

Treatment:

Behavioral: FRAX + Decision Aid

Usual care

No Intervention group

FRAX estimated fracture risk

Experimental group

Treatment:

Behavioral: FRAX estimated fracture risk