Recruiting

RESTORERESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Sponsor:

University of Alabama at Birmingham

Code:

NCT06455085

Conditions

Osteoporosis

Osteoporotic Fractures

Fragility Fracture

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Augmented-Fracture Liaison Service Arm

Enhanced Usual Care Arm

Study Details

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.

Conditions

Osteoporosis

Osteoporotic Fractures

Fragility Fracture

Study ID

NCT06455085

Start date

Dec 16, 2024

Status verified date

Jan, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2634 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Enhanced Usual Care Arm

Participants 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.

Interventions

Augmented-Fracture Liaison Service Arm

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

Enhanced Usual Care Arm

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

Primary outcome measure

Incidence of subsequent fracture [ Time Frame: 24 months post randomization ]

Central Contacts and Locations

Central contacts

Elizabeth M Dye, MSN

205-996-5025 emmills@uabmc.edu

Paolo Rusconi, PhD

205-975-2405 paolorusconi@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Elizabeth M Dye, MSN

205-996-5025 emmills@uabmc.edu

Paolo Rusconi, PhD

205-975-2405 paolorusconi@uabmc.edu

Principal Investigator:

Kenneth Saag, MD, MSc

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Bo D Gregg

480-574-1825 gregg.bodean@mayo.edu

Principal Investigator:

Krupa Doshi, MD

UAMS Health

Recruiting

North Little Rock, Arkansas, United States, 72117

Principal Investigator:

Ryan Hill, MD

University of Florida- Gainesville

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Brittney R Manning, MPH

352-627-9470 broth423@ufl.edu

Melissa T White

352-627-9107 mel6514@ufl.edu

Principal Investigator:

Mei Liu, PhD

University of Florida- Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Lauren DelGiudice

904-244-4692 lauren.delgiudice@jax.ufl.edu

Principal Investigator:

Porter Young, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Mechelle Lockhart

404-967-6860 mechelle.a.lockhart@emory.edu

Principal Investigator:

Camille Vaughan, MD, MS

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Joshlean Fair

312-563-2955 joshlean_fair@rush.edu

Principal Investigator:

Sonali Khandelwal, MD

University of Illinois Chicago (UIC), UI Health

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Vladimir Ilievski

312-996-6060 ilievski@uic.edu

Principal Investigator:

Brian Layden, MD

Loyola University Chicago

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Abigaile Wolak

464-220-9491 awolak2@luc.edu

Principal Investigator:

Pauline Camacho, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Brian Gryzlak

319-335-8218 brian-gryzlak@uiowa.edu

Principal Investigator:

Amal Shibli-Rahhal, MD, MSc, MME

Allina Health Orthopedics/NorthStar Trauma Network

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Ned Tervola

952-914-8594 ned.tervola@allina.com

Principal Investigator:

Gennadiy Busel, MD

Missouri Orthopaedic Institute

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Vicki Jones

573-882-7583 jonesvicki@health.missouri.edu

Principal Investigator:

James L Cook, DVM, PhD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alejandra Aponte

314-273-8827 mariaalejandra@wustl.edu

Principal Investigator:

Mashid Mohseni, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 69198

Contacts

Adam Hornig

402-559-9116 adam.hornig@unmc.edu

Principal Investigator:

Laura Graeff-Armas, MD Graeff-Armas, MD

Dartmouth-Hitchcock Clinic

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Kate Dawson

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

Principal Investigator:

Ugis Gruntmanis, MD

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Erin Sullivan

646-714-6901 sullivane@hss.edu

Principal Investigator:

Emily Stein, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 104661

Contacts

Nathalie Zavala

718-839-7322 nathalie.zavala@einsteinmed.edu

Principal Investigator:

Vafa Tabatabaie, MD

The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Isabella Patterson

984-974-5795 isabella_patterson@med.unc.edu

Principal Investigator:

Donald Caraccio, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Susanne Danus

919-681-4453 susanne.danus@duke.edu

Principal Investigator:

Richard Lee, MD

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Laiton Steele

336-713-3657 laiton.steele@advocatehealth.org

Principal Investigator:

Chris Gillette, PhD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Rece Foss

614-685-3089 rece.foss@osumc.edu

Principal Investigator:

Steven Ing, MD, MSCE

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Niral Patel, MPH

615-936-2474 niral.patel@vumc.org

Kayla Somerville

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

Principal Investigator:

Simpson B Tanner, MD, CCD

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Layla Rivera

713-704-4137 layla.rivera@uth.tmc.edu

Principal Investigator:

Nuzha Amjad, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 5, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-05.