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OpenTrials
Completed

NCT Number: NCT00578981

Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

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.

Completed

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Key information

Age range

50 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteoporosis Choice Decision Aid

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluate ability to recruit participants and collect patient outcomes.

    Time frame: One year after start of study.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 21, 2007
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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