NCT06455085 RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
| NCT ID | NCT06455085 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,634 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,634 participants in total. It began in 2024-12-16 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Kenneth Saag, MD, MSc
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06455085 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06455085 currently recruiting?
Yes, NCT06455085 is actively recruiting participants. Contact the research team at emmills@uabmc.edu for enrollment information.
Where is the NCT06455085 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, North Little Rock, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT06455085 clinical trial?
NCT06455085 is sponsored by University of Alabama at Birmingham. The principal investigator is Kenneth Saag, MD, MSc at University of Alabama at Birmingham. The trial plans to enroll 2,634 participants.