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Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians

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ClinicalTrials.gov Identifier: NCT00949611
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : February 2, 2016
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
Olmsted Medical Center
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic

Brief Summary:

Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

  • FRAX
  • FRAX + decision aid
  • Usual care (no decision aid and no FRAX given to clinician)

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Fragility Fractures Behavioral: FRAX + Decision Aid Behavioral: FRAX estimated fracture risk Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Wiser Choices In Osteoporosis Choice II
Study Start Date : May 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FRAX + Decision Aid Behavioral: FRAX + Decision Aid
Clinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications.
Other Name: Decision Support

No Intervention: Usual care
Experimental: FRAX estimated fracture risk Behavioral: FRAX estimated fracture risk
The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX
Other Name: Risk estimate




Primary Outcome Measures :
  1. Medication start/stop, knowledge, and patient involvement. [ Time Frame: Baseline and at 6 months ]

Secondary Outcome Measures :
  1. Decisional quality. [ Time Frame: Baseline and at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
  • Bone mineral density (BMD) T-Score < 1.0
  • Have appointment with clinician to discuss test results and treatment options
  • Patients with FRAX <20% risk who have taken a bisphosphonate for < 5 years.

Exclusion Criteria:

  • Unable to speak or read English

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): NCT00949611


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Foundation for Informed Medical Decision Making
Olmsted Medical Center
Investigators
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor Montori, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00949611     History of Changes
Other Study ID Numbers: 08-006070
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016

Keywords provided by Victor Montori, Mayo Clinic:
Decision Aid
Shared Decision Making
Shared Medical Decision Making

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases