RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE (RESTORE)

April 29, 2026 updated by: Kenneth Saag, MD, MSc, University of Alabama at Birmingham
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2634

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Kenneth Saag, MD, MSc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Danila, MD, MSc, MSPH
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
        • Principal Investigator:
          • Krupa Doshi, MD
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • UAMS Health
        • Principal Investigator:
          • Ryan Hill, MD
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida- Gainesville
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mei Liu, PhD
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida- Jacksonville
        • Contact:
        • Principal Investigator:
          • Porter Young, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Camille Vaughan, MD, MS
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Sonali Khandelwal, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago (UIC), UI Health
        • Principal Investigator:
          • Brian Layden, MD
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Chicago
        • Contact:
        • Principal Investigator:
          • Pauline Camacho, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Amal Shibli-Rahhal, MD, MSc, MME
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Allina Health Orthopedics/NorthStar Trauma Network
        • Contact:
        • Principal Investigator:
          • Gennadiy Busel, MD
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • Missouri Orthopaedic Institute
        • Contact:
        • Principal Investigator:
          • James L Cook, DVM, PhD
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Contact:
        • Principal Investigator:
          • Mashid Mohseni, MD
    • Nebraska
      • Omaha, Nebraska, United States, 69198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Laura Graeff-Armas, MD Graeff-Armas, MD
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Clinic
        • Contact:
        • Principal Investigator:
          • Ugis Gruntmanis, MD
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital For Special Surgery
        • Contact:
        • Principal Investigator:
          • Emily Stein, MD
      • The Bronx, New York, United States, 104661
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Vafa Tabatabaie, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • The University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Donald Caraccio, MD
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Richard Lee, MD
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Chris Gillette, PhD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Steven Ing, MD, MSCE
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simpson B Tanner, MD, CCD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Houston
        • Contact:
        • Principal Investigator:
          • Nuzha Amjad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • CKD stage 4 or 5 or on dialysis
  • Multiple myeloma
  • Addison's disease
  • Adrenal insufficiency
  • Enrolled hospice care
  • Solid organ transplant, or expecting a solid organ transplant
  • Bone marrow transplant
  • History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease
  • Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)
  • Pathologic fractures secondary to malignancy or infection
  • Scheduled appointment with a bone health specialist
  • Participant unable to consent on their own (cognitive impairment, dementia, etc.)
  • Currently enrolled in another research study that requires taking medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Usual Care Arm
Participants will be mailed education materials and encouraged to follow up with their primary care physician.
Behavioral: Enhanced Usual Care Arm
Patients will be mailed education materials and encouraged to follow up with their primary care physician.
Experimental: Augmented-Fracture Liaison Service Arm
Participants 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.
Behavioral: Augmented-Fracture Liaison Service Arm
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of subsequent fracture
Time Frame: 24 months post randomization
Incidence of fracture 24 months post randomization
24 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Kenneth Saag, MD, MSc, University of Alabama at Birmingham
  • Principal Investigator: Maria Danila, MD, MSPH, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300012444
  • OFP-2022C3-30386 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be made available upon request.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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