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Completed

NCT Number: NCT00949611

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

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)

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Fragility Fractures Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

50 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

FRAX + Decision Aid

Behavioral

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 names: Decision Support

FRAX estimated fracture risk

Behavioral

The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX

Other names: Risk estimate

Primary outcomes

  1. Medication start/stop, knowledge, and patient involvement.

    Time frame: Baseline and at 6 months

Secondary outcomes

  1. Decisional quality.

    Time frame: Baseline and at 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Foundation for Informed Medical Decision Making
  • Olmsted Medical Center

Registry information

Official study title

Wiser Choices In Osteoporosis Choice II

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 30, 2009
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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