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

NCT ID: NCT00949611

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-02-28

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)

Detailed Description

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Conditions

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Osteoporosis Osteopenia Fragility Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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FRAX + Decision Aid

Group Type EXPERIMENTAL

FRAX + Decision Aid

Intervention Type BEHAVIORAL

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.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

FRAX estimated fracture risk

Group Type EXPERIMENTAL

FRAX estimated fracture risk

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

FRAX estimated fracture risk

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Decision Support Risk estimate

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation for Informed Medical Decision Making

OTHER

Sponsor Role collaborator

Olmsted Medical Center

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Victor Montori

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor M. Montori, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015.

Reference Type DERIVED
PMID: 26010755 (View on PubMed)

Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.

Reference Type DERIVED
PMID: 25179289 (View on PubMed)

Other Identifiers

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08-006070

Identifier Type: -

Identifier Source: org_study_id

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