NCT00949611

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

July 28, 2009

Last Update Submit

February 1, 2016

Conditions

OsteoporosisOsteopeniaFragility Fractures

Keywords

Decision AidShared Decision MakingShared Medical Decision Making

Outcome Measures

Primary Outcomes (1)

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

    Baseline and at 6 months

Secondary Outcomes (1)

  • Decisional quality.

    Baseline and at 6 months

Study Arms (3)

FRAX + Decision Aid

EXPERIMENTAL
Behavioral: FRAX + Decision Aid

Usual care

NO INTERVENTION

FRAX estimated fracture risk

EXPERIMENTAL
Behavioral: FRAX estimated fracture risk

Interventions

FRAX + Decision AidBEHAVIORAL

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.

Also known as: Decision Support
FRAX + Decision Aid
FRAX estimated fracture riskBEHAVIORAL

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

Also known as: Risk estimate
FRAX estimated fracture risk

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to speak or read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (2)

  • LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015.

    PMID: 26010755DERIVED

  • Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.

    PMID: 25179289DERIVED

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Victor M. Montori, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 30, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

US(2)