RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE
Purpose
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
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- 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/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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Enhanced Usual Care Arm |
Participants will be mailed education materials and encouraged to follow up with their primary care physician. |
|
|
Experimental 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. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham