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NCT06455085Recruiting

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
2634 (estimated)
First submitted
6 Jun 2024
Start date
16 Dec 2024
Primary completion date
1 Jun 2029
Lead sponsor
University of Alabama at Birmingham
Diseases
Osteoporosis
NCT number
NCT06455085

What you commit to

  • Study type: Interventional
  • Planned participants: 2634
  • From 16 Dec 2024 to the primary completion date, 1 Jun 2029
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Exposure to the following medications in the prior 12 months;
  • Solid organ transplant, or expecting a solid organ transplant
  • Bone marrow transplant
  • Currently enrolled in another research study that requires taking medication

Other illness

  • Diagnosis of the following medical conditions;
  • Addison's disease
  • Adrenal insufficiency
  • History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease
  • Pathologic fractures secondary to malignancy or infection
  • Participant unable to consent on their own (cognitive impairment, dementia, etc.)

Other

  • 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)
  • CKD stage 4 or 5 or on dialysis
  • Multiple myeloma
  • Enrolled hospice care
  • Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)
  • Scheduled appointment with a bone health specialist

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
The University of North Carolina at Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
University of Illinois Chicago (UIC), UI Health
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Missouri Orthopaedic Institute
Coordinator of this site? Confirm its status
ColumbiaUnited StatesRecruiting
The Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Allina Health Orthopedics/NorthStar Trauma Network
Coordinator of this site? Confirm its status
Coon RapidsUnited StatesRecruiting
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
University of Florida - Gainesville
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
UT Health Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
University of Florida - Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Dartmouth-Hitchcock Clinic
Coordinator of this site? Confirm its status
LebanonUnited StatesRecruiting
Loyola University Chicago
Coordinator of this site? Confirm its status
MaywoodUnited StatesRecruiting
Vanderbilt University Medical Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Hospital for Special Surgery
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
UAMS Health
Coordinator of this site? Confirm its status
North Little RockUnited StatesRecruiting
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
Mayo Clinic - Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesRecruiting
Washington University in St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesRecruiting
Wake Forest University Health Sciences
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.