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RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Recruiting
50 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • Age 50 years and older (no upper age limit)
  • Sustained a primary fragility fracture (hip/femur/pelvis, clinical spine, humerus, wrist/forearm) in the last 6 months
  • Participant must self-identify a regular primary care provider (PCP)

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)
    • Miacalcin (calcitonin)
  • Diagnosis of the following medical conditions
    • CKD stage 4 and above
    • Paget's disease
    • Multiple myeloma
    • Osteomalacia
    • Addison's disease
    • Adrenal insufficiency
    • Enrolled hospice care
    • Solid organ transplant
    • Bone marrow transplant
  • Fractures resulting from severe trauma
  • Scheduled appointment with a bone health clinician

Study details
    Osteoporosis
    Osteoporotic Fractures

NCT06455085

University of Alabama at Birmingham

15 October 2025

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