Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

Not Applicable

Completed

• Conditions: Postmenopausal Osteoporosis; Osteoporosis; Bone Loss, Age Related; Postmenopausal Bone Loss
• Interventions: Behavioral: Osteoporosis Choice Decision Aid

• Registration Number: NCT00578981
• Lead Sponsor: Mayo Clinic

Brief Summary

To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.

Detailed Description

Bisphosphonates can reduce fracture risk in patients with osteoporosis. However, many patients may not start and adhere to bisphosphonates, consequently losing independence, quality, and length of life. We hypothesize that a decision aid that efficiently improves patient education and communication with their provider about fracture risk, and about using bisphosphonates to reduce that risk, will improve the quality of treatment decisions. We anticipate that patients will become more involved in the decision-making process and decisions will be more consistent with patients' values and health care goals. We expect this will lead to increased bisphosphonate start and adherence and improved patient outcomes.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female, post-menopausal women aged 50 to 90.
• Have a bone mineral density (BMD) evaluation resulting in a T-Score of <-1.0.
• Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM.
• Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment)
• Enrollment is open to females of diverse racial backgrounds.

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Exclusion Criteria

• Currently taking a bisphosphonate.
• Not available for 6 month follow-up phone call.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	Osteoporosis Choice Decision Aid	-

Primary Outcome Measures

Name	Time	Method
Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication.	Directly following intervention.

Secondary Outcome Measures

Name	Time	Method
Evaluate ability to recruit participants and collect patient outcomes.	One year after start of study.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States