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Recruiting NCT06455085

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Trial Parameters

Condition Osteoporosis
Sponsor University of Alabama at Birmingham
Study Type INTERVENTIONAL
Phase N/A
Enrollment 2,634
Sex ALL
Min Age 50 Years
Max Age N/A
Start Date 2024-12-16
Completion 2029-06-01
Interventions
Augmented-Fracture Liaison Service ArmEnhanced Usual Care Arm

Brief 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

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; * C

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