RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Alabama at Birmingham
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Augmented-Fracture Liaison Service Arm
- Enhanced Usual Care Arm
Treatment groups
2,634 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov