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OsteoporosisRESTORENCT06455085

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

A study testing Augmented-Fracture Liaison Service Arm in people with Osteoporosis and Osteoporotic Fractures, run by University of Alabama at Birmingham at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Augmented-Fracture Liaison Service Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,634 participants
Where
23 sitesUnited States
Study dates
16 Dec 2024to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 28Show fewer
  • 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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth M Dye, MSN contact

205-996-5025

emmills@uabmc.edu

Paolo Rusconi, PhD contact

205-975-2405

paolorusconi@uabmc.edu

23 sites in 1 country

United States23 sites, 23 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Mechelle Lockhart, 404-967-6860, mechelle.a.lockhart@emory.edu

    Camille Vaughan, MD, MS

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Elizabeth M Dye, MSN, 205-996-5025, emmills@uabmc.edu

    Paolo Rusconi, PhD, 205-975-2405, paolorusconi@uabmc.edu

    Recruiting

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Isabella Patterson, 984-974-5795, isabella_patterson@med.unc.edu

    Donald Caraccio, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Joshlean Fair, 312-563-2955, joshlean_fair@rush.edu

    Sonali Khandelwal, MD

    Recruiting

  • University of Illinois Chicago (UIC), UI Health

    Chicago, Illinois, 60612

    Vladimir Ilievski, 312-996-6060, ilievski@uic.edu

    Brian Layden, MD

    Recruiting

  • Missouri Orthopaedic Institute

    Columbia, Missouri, 65212

    Vicki Jones, 573-882-7583, jonesvicki@health.missouri.edu

    James L Cook, DVM, PhD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Rece Foss, 614-685-3089, rece.foss@osumc.edu

    Steven Ing, MD, MSCE

    Recruiting

  • Allina Health Orthopedics/NorthStar Trauma Network

    Coon Rapids, Minnesota, 55433

    Ned Tervola, 952-914-8594, ned.tervola@allina.com

    Gennadiy Busel, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Susanne Danus, 919-681-4453, susanne.danus@duke.edu

    Richard Lee, MD

    Recruiting

  • University of Florida- Gainesville

    Gainesville, Florida, 32611

    Brittney R Manning, MPH, 352-627-9470, broth423@ufl.edu

    Melissa T White, 352-627-9107, mel6514@ufl.edu

    Recruiting

  • UT Health Houston

    Houston, Texas, 77030

    Layla Rivera, 713-704-4137, layla.rivera@uth.tmc.edu

    Nuzha Amjad, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Brian Gryzlak, 319-335-8218, brian-gryzlak@uiowa.edu

    Amal Shibli-Rahhal, MD, MSc, MME

    Recruiting

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209

    Lauren DelGiudice, 904-244-4692, lauren.delgiudice@jax.ufl.edu

    Porter Young, MD

    Recruiting

  • Dartmouth-Hitchcock Clinic

    Lebanon, New Hampshire, 03756

    Kate Dawson, 603-650-3769, Kate.E.Dawson@hitchcock.org

    Ugis Gruntmanis, MD

    Recruiting

  • Loyola University Chicago

    Maywood, Illinois, 60153

    Abigaile Wolak, 464-220-9491, awolak2@luc.edu

    Pauline Camacho, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Niral Patel, MPH, 615-936-2474, niral.patel@vumc.org

    Kayla Somerville, 615-875-5683, kayla.n.somerville.1@vumc.org

    Recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Erin Sullivan, 646-714-6901, sullivane@hss.edu

    Emily Stein, MD

    Recruiting

  • UAMS Health

    North Little Rock, Arkansas, 72117

    Ryan Hill, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 69198

    Adam Hornig, 402-559-9116, adam.hornig@unmc.edu

    Laura Graeff-Armas, MD Graeff-Armas, MD

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Bo D Gregg, 480-574-1825, gregg.bodean@mayo.edu

    Krupa Doshi, MD

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63110

    Alejandra Aponte, 314-273-8827, mariaalejandra@wustl.edu

    Mashid Mohseni, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 104661

    Nathalie Zavala, 718-839-7322, nathalie.zavala@einsteinmed.edu

    Vafa Tabatabaie, MD

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Laiton Steele, 336-713-3657, laiton.steele@advocatehealth.org

    Chris Gillette, PhD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Augmented-Fracture Liaison Service Arm, Enhanced Usual Care Arm
Medical subject headings
Osteoporosis, Osteoporotic Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented-Fracture Liaison Service ArmBehavioural

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

  • Enhanced Usual Care ArmBehavioural

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

Study groups in NCT06455085
Study groupRoleWhat they receive
Enhanced Usual Care ArmActive comparatorParticipants will be mailed education materials and encouraged to follow up with their primary care physician.
Receives: Behavioral: Enhanced Usual Care Arm
Augmented-Fracture Liaison Service ArmExperimentalParticipants 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.
Receives: Behavioral: Augmented-Fracture Liaison Service Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of subsequent fracture

    Incidence of fracture 24 months post randomization

    Measured: 24 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start16 Dec 2024
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,634 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455085
Sponsor's protocol ID
IRB-300012444
Other IDs
OFP-2022C3-30386
Acronym
RESTORE
Status last verified
Jan 2026
First submitted
6 Jun 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data will be made available upon request.

Questions about this trial

What is this clinical trial studying?

A study testing Augmented-Fracture Liaison Service Arm in people with Osteoporosis and Osteoporotic Fractures, run by University of Alabama at Birmingham at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth M Dye, MSN (205-996-5025, emmills@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of subsequent fracture (time frame: 24 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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