RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,634
- Locations
- 21
- Primary Endpoint
- Incidence of subsequent fracture
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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)
Arms & Interventions
Enhanced Usual Care Arm
Participants will be mailed education materials and encouraged to follow up with their primary care physician.
Intervention: Enhanced Usual Care Arm (Behavioral)
Augmented-Fracture Liaison Service Arm
Participants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment.
Intervention: Augmented-Fracture Liaison Service Arm (Behavioral)
Outcomes
Primary Outcomes
Incidence of subsequent fracture
Time Frame: 24 months post randomization
Incidence of fracture 24 months post randomization
Secondary Outcomes
No secondary outcomes reported
Investigators
Kenneth Saag, MD, MSc
Professor of Medicine
University of Alabama at Birmingham