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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Augmented-Fracture Liaison Service Arm
BehavioralPatients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
Enhanced Usual Care Arm
BehavioralPatients will be mailed education materials and encouraged to follow up with their primary care physician.
Treatment groups
2,634 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual Care ArmActive comparator 1 intervention
Group B: Augmented-Fracture Liaison Service ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of subsequent fracture
Incidence of fracture 24 months post randomization
Time frame
24 months post randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov