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
- Fragility Fracture
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible 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) - Natpara (parathyroid hormone) - Evista (raloxifene) - Duavee (bazedoxifene-conjugated estrogen) - Miacalcin (calcitonin) - Diagnosis of the following medical conditions; - CKD stage 4 or 5 or on dialysis - Multiple myeloma - Addison's disease - Adrenal insufficiency - Enrolled hospice care - Solid organ transplant, or expecting a solid organ transplant - Bone marrow transplant - History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease - Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation) - Pathologic fractures secondary to malignancy or infection - Scheduled appointment with a bone health specialist - Participant unable to consent on their own (cognitive impairment, dementia, etc.) - Currently enrolled in another research study that requires taking medication
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
Mayo Clinic Arizona
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
University of Florida- Gainesville
Gainesville, Florida 32611
Gainesville, Florida 32611
University of Florida- Jacksonville
Jacksonville, Florida 32209
Jacksonville, Florida 32209
Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Illinois Chicago (UIC), UI Health
Chicago, Illinois 60612
Chicago, Illinois 60612
Loyola University Chicago
Maywood, Illinois 60153
Maywood, Illinois 60153
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Allina Health Orthopedics/NorthStar Trauma Network
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Missouri Orthopaedic Institute
Columbia, Missouri 65212
Columbia, Missouri 65212
Washington University in St. Louis
St Louis, Missouri 63110
St Louis, Missouri 63110
University of Nebraska Medical Center
Omaha, Nebraska 69198
Omaha, Nebraska 69198
Hospital for Special Surgery
New York, New York 10021
New York, New York 10021
Montefiore Medical Center
The Bronx, New York 104661
The Bronx, New York 104661
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University
Durham, North Carolina 27710
Durham, North Carolina 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- NCT ID
- NCT06455085
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham