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Improving outcomes for patients with fragility fractures

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Not applicable Interventional University of Alabama at Birmingham · NCT06455085

This study is testing if a new support program for older adults with recent bone fractures can help them recover better than standard care that just provides education.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2634 (estimated)
Ages50 Years and up
SexAll
SponsorUniversity of Alabama at Birmingham Academic / other
Drugs / interventionsdenosumab, romozosumab
Locations23 sites (Birmingham, Alabama and 22 other locations)
Trial IDNCT06455085 on ClinicalTrials.gov

What this trial studies

RESTORE evaluates the effectiveness of an Augmented Fracture Liaison Service, where patients receive support from a navigator and are referred to bone health providers, compared to Enhanced Usual Care that focuses on education for patients and primary care providers. The study aims to assess how factors such as age, race, ethnicity, sex, poverty level, geographic region, and timing of entry after a fracture influence the success of these two approaches. Participants must be 50 years or older and have experienced a primary fragility fracture within the last six months.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older who have sustained a primary fragility fracture in the last six months.

Not a fit: Patients who have been treated with specific osteoporosis medications in the past year or have certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and outcomes for patients suffering from osteoporosis and fragility fractures.

How similar studies have performed: Other studies have shown promise in using fracture liaison services to improve patient outcomes, indicating that this approach is supported by existing evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions OsteoporosisOsteoporotic FracturesFragility Fracture
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.