NCT06455085Recruiting
RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2634 (estimated)
- First submitted
- 6 Jun 2024
- Start date
- 16 Dec 2024
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Osteoporosis
- NCT number
- NCT06455085
What you commit to
- Study type: Interventional
- Planned participants: 2634
- From 16 Dec 2024 to the primary completion date, 1 Jun 2029
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to the following medications in the prior 12 months;
- Solid organ transplant, or expecting a solid organ transplant
- Bone marrow transplant
- Currently enrolled in another research study that requires taking medication
Other illness
- Diagnosis of the following medical conditions;
- Addison's disease
- Adrenal insufficiency
- History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease
- Pathologic fractures secondary to malignancy or infection
- Participant unable to consent on their own (cognitive impairment, dementia, etc.)
Other
- 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)
- CKD stage 4 or 5 or on dialysis
- Multiple myeloma
- Enrolled hospice care
- Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)
- Scheduled appointment with a bone health specialist
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| The University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Illinois Chicago (UIC), UI Health Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Missouri Orthopaedic Institute Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Allina Health Orthopedics/NorthStar Trauma Network Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| University of Florida - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| UT Health Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Florida - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Dartmouth-Hitchcock Clinic Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Loyola University Chicago Coordinator of this site? Confirm its status | Maywood | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Hospital for Special Surgery Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| UAMS Health Coordinator of this site? Confirm its status | North Little Rock | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.