RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
University of Alabama at Birmingham
2,634 participants
Dec 16, 2024
INTERVENTIONAL
Conditions
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 Criteria5
- 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 Criteria28
- 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
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Interventions
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
Patients will be mailed education materials and encouraged to follow up with their primary care physician.
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06455085