RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Recruiting now · Not applicable

Conditions studied: Osteoporosis, Osteoporotic Fractures, Fragility Fracture

In brief

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 facts

Study ID

NCT06455085

Run by

University of Alabama at Birmingham

People needed

2634

Starts

2024-12-16

Expected to finish

2029-06-01

Last updated by the study team

2026-05-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• UAMS Health — North Little Rock, Arkansas, United States (enrolling)
• University of Florida- Gainesville — Gainesville, Florida, United States (enrolling)
• University of Florida- Jacksonville — Jacksonville, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• University of Illinois Chicago (UIC), UI Health — Chicago, Illinois, United States (enrolling)
• Loyola University Chicago — Maywood, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Allina Health Orthopedics/NorthStar Trauma Network — Coon Rapids, Minnesota, United States (enrolling)
• Missouri Orthopaedic Institute — Columbia, Missouri, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Dartmouth-Hitchcock Clinic — Lebanon, New Hampshire, United States (enrolling)
• Hospital for Special Surgery — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• UT Health Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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