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NCT06455085NARecruiting

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

University of Alabama at Birmingham

Start Date

12/16/2024

Completion Date

6/1/2029

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.

Eligibility Criteria

Age Range: 50 years to No maximum

Inclusion Criteria: * Age 50 years and older (no upper age limit) * Sustained a primary fragility fracture (hip/femur, pelvis, clinical spine, humerus, wrist) in the last 12 months * Participant must self-identify a regular primary care provider (PCP) * Participant must provide a mailing address * Participant must plan to remain geographically proximate (able to travel if necessary) to the site from which they are recruited over the next several months Exclusion Criteria: * Exposure to the following medications in the prior 12 months; * Actonel or Atelvia (risedronate) * Fosamax or Binosto (alendronate) * Reclast, Zometa, or Aclasta (zoledronic acid, zoledronate) * Boniva or Bondronat (ibandronate) * Aredia (pamidronate) * Prolia (denosumab) * Evenity (romozosumab) * Tymlos (abaloparatide) * Forteo (teriparatide) * Natpara (parathyroid hormone) * Evista (raloxifene) * Duavee (bazedoxifene-conjugated estrogen) * Miacalcin (calcitonin) * Diagnosis of the following medical conditions; * CKD stage 4 or 5 or on dialysis * Multiple myeloma * Addison's disease * Adrenal insufficiency * Enrolled hospice care * Solid organ transplant, or expecting a solid organ transplant * Bone marrow transplant * History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease * Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation) * Pathologic fractures secondary to malignancy or infection * Scheduled appointment with a bone health specialist * Participant unable to consent on their own (cognitive impairment, dementia, etc.) * Currently enrolled in another research study that requires taking medication

Interventions

BEHAVIORAL

Augmented-Fracture Liaison Service Arm

BEHAVIORAL

Enhanced Usual Care Arm

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Conditions

OsteoporosisOsteoporotic FracturesFragility Fracture

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Mayo Clinic Arizona

Scottsdale, Arizona 85259

United States

UAMS Health

North Little Rock, Arkansas 72117

United States

University of Florida- Gainesville

Gainesville, Florida 32611

United States

University of Florida- Jacksonville

Jacksonville, Florida 32209

United States

Emory University

Atlanta, Georgia 30322

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

University of Illinois Chicago (UIC), UI Health

Chicago, Illinois 60612

United States

Loyola University Chicago

Maywood, Illinois 60153

United States

University of Iowa

Iowa City, Iowa 52242

United States

Allina Health Orthopedics/NorthStar Trauma Network

Coon Rapids, Minnesota 55433

United States

Missouri Orthopaedic Institute

Columbia, Missouri 65212

United States

Washington University in St. Louis

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 69198

United States

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire 03756

United States

Hospital for Special Surgery

New York, New York 10021

United States

Montefiore Medical Center

The Bronx, New York 104661

United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Duke University

Durham, North Carolina 27710

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

The Ohio State University

Columbus, Ohio 43210

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

UT Health Houston

Houston, Texas 77030

United States