NCT06455085

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,634 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Osteoporotic Fractures
• Fragility Fracture

Interventions

Type	Name	Description
BEHAVIORAL	Augmented-Fracture Liaison Service Arm	Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
BEHAVIORAL	Enhanced Usual Care Arm	Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Timeline

• Start date: 2024-12-16
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2024-06-12
• Last updated: 2026-01-08

Locations

21 sites across 1 country: United States