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NCT06455085 · ClinicalTrials.gov registry record · NA
RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
A NA study of Osteoporosis and Fragility Fracture, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 2,634
- Enrollment target
- 20
- Study locations
NCT06455085: Recruiting NA study of Osteoporosis and Fragility Fracture, sponsored by University of Alabama at Birmingham.
NCT06455085 is a NA study of Osteoporosis and Fragility Fracture that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 2,634 participants, above the 1,515-participant average among 84 other Osteoporosis trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06455085, a NA study of Osteoporosis and Fragility Fracture, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,634 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Incidence of fracture 24 months post randomization
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 |
What NCT06455085 shows while recruiting
NCT06455085 is an interventional study that assigns participants to a tested intervention. Its 2,634 participants enrollment target places it among the larger protocols in the corpus, above the 1,515-participant average among 84 other Osteoporosis trials with a reported enrollment target (74% higher).
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.
NCT06455085 names 20 study sites across 13 states, led by Illinois, North Carolina, Florida.
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.
What interventions are being tested in trial NCT06455085?
The interventions under investigation include: Augmented-Fracture Liaison Service Arm (BEHAVIORAL), Enhanced Usual Care Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT06455085?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06455085's enrollment target sits among peer trials
2,634 7th of 84 higher than 78 of 84 other Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoporosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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