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RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

NCT06455085 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2634

Last updated 2026-05-05

No results posted yet for this 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

Interventions

BEHAVIORAL

Augmented-Fracture Liaison Service Arm

Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.

BEHAVIORAL

Enhanced Usual Care Arm

Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Kenneth Saag, MD, MSc · University of Alabama at Birmingham

  • Maria Danila, MD, MSPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2029-06-01
Completion
2029-06-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455085 on ClinicalTrials.gov