Tests a patient navigator follow-up plan for people with fragility fractures
Tests a navigator-led bone health referral program in adults 50 and older with fragility fractures.
Plain-language title generated from the registry record
Registry title: RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
Key facts
- Where
- Atlanta, Birmingham, Chapel Hill, Chicago, Columbia, Columbus, Coon Rapids, Durham, Gainesville, Houston, Iowa City, Jacksonville, Lebanon, Maywood, Nashville, New York, North Little Rock, Omaha, Scottsdale, St Louis, The Bronx, and Winston-Salem, United StatesSee the 23 sites
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- The University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of Illinois Chicago (UIC), UI HealthChicago, United StatesTaking people
- Missouri Orthopaedic InstituteColumbia, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Allina Health Orthopedics/NorthStar Trauma NetworkCoon Rapids, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- University of Florida - GainesvilleGainesville, United StatesTaking people
- UT Health HoustonHouston, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- University of Florida - JacksonvilleJacksonville, United StatesTaking people
- Dartmouth-Hitchcock ClinicLebanon, United StatesTaking people
- Loyola University ChicagoMaywood, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Hospital for Special SurgeryNew York, United StatesTaking people
- UAMS HealthNorth Little Rock, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- Mayo Clinic - ArizonaScottsdale, United StatesTaking people
- Washington University in St. LouisSt Louis, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alabama at Birmingham
- Trial code
- NCT06455085
- Record updated
- 5 May 2026
- Original description
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.Read full original descriptionShow less
RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
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.
Inclusion: 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: Exposure to the following medications in the prior 12 months; Solid organ transplant, or expecting a solid organ transplant; Bone marrow transplant; Currently enrolled in another research study that requires taking medication; Diagnosis of the following medical conditions; Addison's disease; Adrenal insufficiency; History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease; Pathologic fractures secondary to malignancy or infection; Participant unable to consent on their own (cognitive impairment, dementia, etc.); 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); CKD stage 4 or 5 or on dialysis; Multiple myeloma; Enrolled hospice care; Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation); Scheduled appointment with a bone health specialist.