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.
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.
Conditions
- Osteoporosis
- Bone Loss, Age Related
- Postmenopausal Bone Loss
- Postmenopausal Osteoporosis
Study Type
Interventional
Study Design
Other, Randomised, Single Blind (Subject), Active Control, Factorial Assignment, Efficacy Study.
Further Details
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Evaluate ability to recruit participants and collect patient outcomes.
Study Start
August 2007
Eligibility & Criteria
- 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.
Total Enrolment
100
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578981
Mayo Clinic Recruiting
Rochester, Minnesota
United States, 55905
Contacts:
Laurie J Pencille
507-538-6801
pencille.laurie@mayo.eduRebecca Mullan
(507)538-3246
mullan.rebecca@mayo.edu
Principal Investigator:
Brian A Swiglo, BA, MD.
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