Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

Wiser Choices in Osteoporosis Trial: The OSTEOPOROSIS CHOICE Decision Aid to Support the Decision to Use or Not Use Bisphosphonates in Postmenopausal Women at Risk of Osteoporotic Fractures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578981
• Other study ID #: 07-003475
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: February 1, 2016
• Start date: August 2007
• Est. completion date: July 2008

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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.

Exclusion Criteria:

• Currently taking a bisphosphonate.

• Not available for 6 month follow-up phone call.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Bone Loss, Age Related
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Bone Loss
• Postmenopausal Osteoporosis

Intervention

Behavioral:
• Osteoporosis Choice Decision Aid
The provider will introduce the patient to the choice of bisphosphonates using the decision aid.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Evaluate ability to recruit participants and collect patient outcomes.		One year after start of study.	No

External Links

•   Mayo Clinic Clinical Trials