RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jun 6, 2024

Keywords

ClinConnect Summary

The RESTORE trial is studying two different ways to help people with osteoporosis, a condition that makes bones weak and more likely to break. The main goal is to see if a program called Augmented-FLS, where a patient navigator helps connect individuals to bone health providers, is more effective than Enhanced Usual Care, which focuses on educating patients and their primary care doctors. This trial will also look at how factors like age, race, and where someone lives might affect the success of these approaches.

To participate, you need to be 50 years or older and have had a specific type of bone fracture in the last six months. You should also have a regular doctor for your primary care. However, if you've taken certain medications for bone health in the past year or have specific health conditions, you may not be eligible. If you join the trial, you can expect support and guidance as you learn more about managing your bone health. It's an opportunity to potentially improve your health outcomes after a fracture.

Gender

ALL

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/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