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

Osteoporosis Clinical Trial

Official title:

Wiser Choices In Osteoporosis Choice II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949611
• Other study ID #: 08-006070
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: February 1, 2016
• Start date: May 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fragility Fractures
• Osteopenia
• Osteoporosis

Intervention

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.
• FRAX estimated fracture risk
The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Foundation for Informed Medical Decision Making, Olmsted Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication start/stop, knowledge, and patient involvement.		Baseline and at 6 months	No
Secondary	Decisional quality.		Baseline and at 6 months	No