RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented-Fracture Liaison Service Arm, Enhanced Usual Care Arm.
- Who it may be relevant to
- Registry conditions: Osteoporosis, Osteoporotic Fractures, Fragility Fracture. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Augmented-Fracture Liaison Service Arm
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician. - Behavioral Enhanced Usual Care Arm
Patients will be mailed education materials and encouraged to follow up with their primary care physician.
Primary outcome measures
- Incidence of subsequent fracture [Time frame: 24 months post randomization]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 23 centers
- University of Alabama at Birmingham — Birmingham
- Mayo Clinic Arizona — Scottsdale
- UAMS Health — North Little Rock
- University of Florida- Gainesville — Gainesville
- University of Florida- Jacksonville — Jacksonville
- Emory University — Atlanta
- Rush University Medical Center — Chicago
- University of Illinois Chicago (UIC), UI Health — Chicago
- … and 15 more centers
Identifiers
NCT: NCT06455085 · IRB-300012444 · OFP-2022C3-30386