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Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00578981
First Posted: December 21, 2007
Last Update Posted: February 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic
  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: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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:


Further study details as provided by Victor Montori, 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. ]

Secondary Outcome Measures:
  • Evaluate ability to recruit participants and collect patient outcomes. [ Time Frame: One year after start of study. ]

Enrollment: 100
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Behavioral: Osteoporosis Choice Decision Aid
The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
No Intervention: Arm 2

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor Montori, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00578981     History of Changes
Other Study ID Numbers: 07-003475
First Submitted: December 20, 2007
First Posted: December 21, 2007
Last Update Posted: February 2, 2016
Last Verified: February 2016

Keywords provided by Victor Montori, Mayo Clinic:
Osteoporosis, age-related
Osteoporosis, Postmenopausal
Bone Loss
Low Bone Density

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs