RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
RESTORE
2 other identifiers
interventional
2,634
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
May 5, 2026
January 1, 2026
4.5 years
June 6, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of subsequent fracture
Incidence of fracture 24 months post randomization
24 months post randomization
Study Arms (2)
Enhanced Usual Care Arm
ACTIVE COMPARATORParticipants will be mailed education materials and encouraged to follow up with their primary care physician.
Augmented-Fracture Liaison Service Arm
EXPERIMENTALParticipants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment.
Interventions
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
Patients will be mailed education materials and encouraged to follow up with their primary care physician.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Exposure to the following medications in the prior 12 months;
- 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)
- Diagnosis of the following medical conditions;
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
UAMS Health
North Little Rock, Arkansas, 72117, United States
University of Florida- Gainesville
Gainesville, Florida, 32611, United States
University of Florida- Jacksonville
Jacksonville, Florida, 32209, United States
Emory University
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Chicago (UIC), UI Health
Chicago, Illinois, 60612, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Allina Health Orthopedics/NorthStar Trauma Network
Coon Rapids, Minnesota, 55433, United States
Missouri Orthopaedic Institute
Columbia, Missouri, 65212, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 69198, United States
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 104661, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Health Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Saag, MD, MSc
University of Alabama at Birmingham
- PRINCIPAL INVESTIGATOR
Maria Danila, MD, MSPH
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 6, 2024
First Posted
June 12, 2024
Study Start
December 16, 2024
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
May 5, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study protocol, SAP, and ICF will be made available upon request at conclusion of the study and after study scientific reports (e.g. abstracts, journal articles) are published.
Anonymized data will be made available upon request.