Clinical trial NCT00578981: Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Bone Loss, Age Related
Postmenopausal Bone Loss
Postmenopausal Osteoporosis
Keywords: Osteoporosis, age-related
Osteoporosis, Postmenopausal
Bone Loss
Low Bone Density
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-12-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Directly following intervention.
Secondary outcomes:
measure: Evaluate ability to recruit participants and collect patient outcomes.
timeFrame: One year after start of study.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Victor M. Montori, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
citation: Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Melton LJ 3rd, Wermers RA. Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med. 2011 Jun;124(6):549-56. doi: 10.1016/j.amjmed.2011.01.013.
citation: Pencille LJ, Campbell ME, Van Houten HK, Shah ND, Mullan RJ, Swiglo BA, Breslin M, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Wermers RA, Melton LJ 3rd, Montori VM. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice. Trials. 2009 Dec 10;10:113. doi: 10.1186/1745-6215-10-113.