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โ† Trials
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RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

RecruitingNAAges 50 Years - anyAllUniversity of Alabama at Birmingham
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Augmented-Fracture Liaison Service Arm
  • Enhanced Usual Care Arm
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Where

23 sites
University of Alabama at Birmingham
Birmingham, United States
Mayo Clinic Arizona
Scottsdale, United States
UAMS Health
North Little Rock, United States
University of Florida- Gainesville
Gainesville, United States
University of Florida- Jacksonville
Jacksonville, United States
Emory University
Atlanta, United States
Rush University Medical Center
Chicago, United States
University of Illinois Chicago (UIC), UI Health
Chicago, United States

โ€ฆand 15 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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