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

NCT00949611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2016-02-02

No results posted yet for this study

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)

Conditions

Interventions

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.

BEHAVIORAL

FRAX estimated fracture risk

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

Sponsors & Collaborators

  • Foundation for Informed Medical Decision Making

    collaborator OTHER

  • Olmsted Medical Center

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Victor M. Montori, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949611 on ClinicalTrials.gov