RESTORE: Reducing Future Fractures and Improving Outcomes of Fragility Fracture

The RESTORE study is looking at ways to prevent future broken bones (fractures) in people who have recently had a fragility fracture (a break from a fall from standing height or less). This study compares two approaches: "Augmented-Fracture Liaison Service" where a patient navigator helps you connect with a bone health doctor, and "Enhanced Usual Care" which provides educational materials and encourages you to see your primary care doctor. We want to see which approach is better at preventing more fractures over 24 months. You may be able to join if you are 50 or older, have had a recent fragility fracture (like a hip, wrist, or spine fracture) in the last 12 months, and have a primary care doctor. The study is currently recruiting 2634 participants.

Study design
This interventional study plans to enroll 2634 participants. It compares two different behavioral interventions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after being assigned to a group to track subsequent fractures.

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NCT06455085

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Recruiting
NAAges 50+InterventionalPrevention
University of Alabama at Birmingham
~2,634 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Augmented-Fracture Liaison Service ArmEnhanced Usual Care Arm

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of subsequent fracture
Measured over 24 months post randomization
Osteoporosis
Osteoporotic Fractures
Fragility Fracture
23 sites across 16 states
Illinois3
North Carolina3
Florida2
Missouri2
New York2
Alabama1
Arizona1
Arkansas1
  • Kenneth Saag, MD, MSc · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
  • Maria Danila, MD, MSPH · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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

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
  • Incidence of subsequent fracture24 months post randomization

    Incidence of fracture 24 months post randomization