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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2634

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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