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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 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.

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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.

Conditions Studied

Osteoporosis Fragility Fracture Osteoporotic Fractures

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

FieldValue
Enrollment Target 2,634 participants
Start Date 2024-12-16
Est. Completion 2029-06-01
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

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What the Registry Record Tells You About NCT06455085

The ClinicalTrials.gov registry entry for NCT06455085 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,634 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,515-participant average among 84 other Osteoporosis trials with a reported enrollment target (74% higher). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.