Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

NCT ID: NCT00578981

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis Bone Loss, Age Related Postmenopausal Bone Loss Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Osteoporosis Choice Decision Aid

Intervention Type BEHAVIORAL

The provider will introduce the patient to the choice of bisphosphonates using the decision aid.

Arm 2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Osteoporosis Choice Decision Aid

The provider will introduce the patient to the choice of bisphosphonates using the decision aid.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Victor Montori

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor M. Montori, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25179289 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21605732 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20003299 (View on PubMed)

Other Identifiers

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07-003475

Identifier Type: -

Identifier Source: org_study_id

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