Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis Bone Loss, Age Related Postmenopausal Bone Loss Postmenopausal Osteoporosis |
Behavioral: Osteoporosis Choice Decision Aid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) |
| 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. |
- 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. [ Time Frame: Directly following intervention. ] [ Designated as safety issue: No ]
- Evaluate ability to recruit participants and collect patient outcomes. [ Time Frame: One year after start of study. ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | August 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Behavioral: Osteoporosis Choice Decision Aid
The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
|
| No Intervention: Arm 2 |
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.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female, post-menopausal women aged 50 to 90.
- Have a BMD evaluation resulting in a T-Score of <-1.0.
- Have a follow-up appointment with a provider in the areas of FM, 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.
Contacts and Locations More Information
Additional Information:
No publications provided by Mayo Clinic
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Victor Montori, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00578981 History of Changes |
| Other Study ID Numbers: | 07-003475 |
| Study First Received: | December 20, 2007 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Osteoporosis, age-related Osteoporosis, Postmenopausal Bone Loss Low Bone Density |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Osteoporotic Fractures Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Fractures, Bone Wounds and Injuries Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013