RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
NCT ID: NCT06455085
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2634 participants
INTERVENTIONAL
2024-12-16
2029-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Enhanced Usual Care Arm
Participants will be mailed education materials and encouraged to follow up with their primary care physician.
Enhanced Usual Care Arm
Patients will be mailed education materials and encouraged to follow up with their primary care physician.
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.
Augmented-Fracture Liaison Service Arm
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Kenneth Saag, MD, MSc
Professor of Medicine
Principal Investigators
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Kenneth Saag, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Maria Danila, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Florida- Gainesville
Gainesville, Florida, United States
University of Florida- Jacksonville
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Chicago (UIC), UI Health
Chicago, Illinois, United States
Loyola University Chicago
Maywood, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Allina Health Orthopedics/NorthStar Trauma Network
Coon Rapids, Minnesota, United States
Missouri Orthopaedic Institute
Columbia, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hospital for Special Surgery
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Health Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OFP-2022C3-30386
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300012444
Identifier Type: -
Identifier Source: org_study_id
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