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RECRUITING
NCT06455085
NA

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2634

Start Date

2024-12-16

Completion Date

2029-06-01

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Augmented-Fracture Liaison Service Arm

Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.

BEHAVIORAL

Enhanced Usual Care Arm

Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Locations (21)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

University of Florida- Gainesville

Gainesville, Florida, United States

University of Florida- Jacksonville

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois Chicago (UIC), UI Health

Chicago, Illinois, United States

Loyola University Chicago

Maywood, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Allina Health Orthopedics/NorthStar Trauma Network

Coon Rapids, Minnesota, United States

Missouri Orthopaedic Institute

Columbia, Missouri, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hospital for Special Surgery

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Health Houston

Houston, Texas, United States