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RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Recruiting

Who can join

Ages 50 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: University of Alabama at Birmingham · Participants: 2,634 · Started: Dec 16, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06455085

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArizonaMayo Clinic Arizona, Scottsdale
ArkansasUAMS Health, North Little Rock
FloridaUniversity of Florida- Gainesville, Gainesville
University of Florida- Jacksonville, Jacksonville
GeorgiaEmory University, Atlanta
IllinoisRush University Medical Center, Chicago
University of Illinois Chicago (UIC), UI Health, Chicago
Loyola University Chicago, Maywood
IowaUniversity of Iowa, Iowa City
MinnesotaAllina Health Orthopedics/NorthStar Trauma Network, Coon Rapids
MissouriMissouri Orthopaedic Institute, Columbia
Washington University in St. Louis, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New HampshireDartmouth-Hitchcock Clinic, Lebanon
New YorkHospital for Special Surgery, New York
Montefiore Medical Center, The Bronx
North CarolinaThe University of North Carolina at Chapel Hill, Chapel Hill
Duke University, Durham
Wake Forest University Health Sciences, Winston-Salem
OhioThe Ohio State University, Columbus
TennesseeVanderbilt University Medical Center, Nashville
TexasUT Health Houston, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.