RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE (NCT06455085) | Clinical Trial Compass
RecruitingNot Applicable
RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
United States2,634 participantsStarted 2024-12-16
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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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…