NCT06455085

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Official Title:

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

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

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

Disease(s) and\or Condition(s)

Osteoporosis

Osteoporotic Fractures

Fragility Fracture

Primary Purpose
  • PREVENTION
Intervention/Treatment
    • Type: BEHAVIORAL
    • Name: Augmented-Fracture Liaison Service Arm
    • Description: Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
    • Arm Group Labels: Augmented-Fracture Liaison Service Arm
    • Type: BEHAVIORAL
    • Name: Enhanced Usual Care Arm
    • Description: Patients will be mailed education materials and encouraged to follow up with their primary care physician.
    • Arm Group Labels: Enhanced Usual Care Arm
Sponsor
  • University of Alabama at Birmingham