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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00949611
• Collaborator: Foundation for Informed Medical Decision Making (Other), Olmsted Medical Center (Other)
• Enrollment: 79
• Locations: 2
• Arms: 3
• Duration (Months): 21.1
• Patients Per Site: 39.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Osteopenia; Fragility Fractures	Behavioral: FRAX + Decision Aid; Behavioral: FRAX estimated fracture risk	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Wiser Choices In Osteoporosis Choice II
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FRAX + Decision Aid	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.; Other Names: Decision Support
No Intervention: Usual care
Experimental: FRAX estimated fracture risk	Behavioral: FRAX estimated fracture risk; The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX; Other Names: Risk estimate

Outcome Measures

Primary Outcome Measures

1. Medication start/stop, knowledge, and patient involvement. [Baseline and at 6 months]

Secondary Outcome Measures

1. Decisional quality. [Baseline and at 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55901
2	Mayo Clinic	Rochester	Minnesota	United States	55902

Sponsors and Collaborators

• Mayo Clinic
• Foundation for Informed Medical Decision Making
• Olmsted Medical Center

Investigators

• Principal Investigator: Victor M. Montori, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Victor Montori, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00949611
• Other Study ID Numbers: 08-006070
• First Posted: Jul 30, 2009
• Last Update Posted: Feb 2, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Victor Montori, MD, Mayo Clinic: Decision Aid; Shared Decision Making; Shared Medical Decision Making
• Additional relevant MeSH terms: Osteoporosis; Bone Diseases, Metabolic

Study Results

No Results Posted as of Feb 2, 2016