Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00578981

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:	Randomized, Single Blind (Subject), Active Control, Factorial Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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. [ Time Frame: Directly following intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate ability to recruit participants and collect patient outcomes. [ Time Frame: One year after start of study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2010
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Behavioral: Osteoporosis Choice Decision Aid The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
Arm 2: No Intervention

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578981

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Victor M. Montori, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Mayo Clinic ( Brian Swiglo, M.D. )
Study ID Numbers:	07-003475
Study First Received:	December 20, 2007
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00578981 History of Changes
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:

Diphosphonates
Osteoporosis
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Physiological Effects of Drugs

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010