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RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
NCT06455085 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Augmented-Fracture Liaison Service Arm
- BEHAVIORAL Enhanced Usual Care Arm
Study Locations (20)
Illinois
- Rush University Medical Center — Chicago
- University of Illinois Chicago (UIC), UI Health — Chicago
- Loyola University Chicago — Maywood
North Carolina
- The University of North Carolina at Chapel Hill — Chapel Hill
- Duke University — Durham
- Wake Forest University Health Sciences — Winston-Salem
Florida
- University of Florida- Gainesville — Gainesville
- University of Florida- Jacksonville — Jacksonville
Missouri
- Missouri Orthopaedic Institute — Columbia
- Washington University in St. Louis — St Louis
New York
- Hospital for Special Surgery — New York
- Montefiore Medical Center — The Bronx
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Mayo Clinic Arizona — Scottsdale
Georgia
- Emory University — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,634 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2029-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455085
The ClinicalTrials.gov registry entry for NCT06455085 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,634 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Osteoporosis appearing as the primary indexed condition, and to 2 interventions — of which Augmented-Fracture Liaison Service Arm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06455085 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Illinois, North Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06455085 about?
NCT06455085 is a clinical study titled "RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE". 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, ...
What is the current status of trial NCT06455085?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,634 participants. The study started on 2024-12-16. Estimated completion is 2029-06-01.
What conditions does trial NCT06455085 study?
This clinical trial studies the following conditions: Osteoporosis, Fragility Fracture, Osteoporotic Fractures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06455085?
The interventions under investigation include: Augmented-Fracture Liaison Service Arm (BEHAVIORAL), Enhanced Usual Care Arm (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06455085?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06455085 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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