RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06455085

Acronym

RESTORE

Enrollment

2634

Registered

2024-06-12

Start date

2024-12-16

Completion date

2029-06-01

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragility Fracture, Osteoporosis, Osteoporotic Fractures

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.

Interventions

BEHAVIORALAugmented-Fracture Liaison Service Arm

Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.

BEHAVIORALEnhanced Usual Care Arm

Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of subsequent fracture	24 months post randomization	Incidence of fracture 24 months post randomization

Countries

United States

Contacts

CONTACTElizabeth M Dye, MSN

emmills@uabmc.edu205-996-5025

CONTACTPaolo Rusconi, PhD

paolorusconi@uabmc.edu205-975-2405

PRINCIPAL_INVESTIGATORKenneth Saag, MD, MSc

University of Alabama at Birmingham

PRINCIPAL_INVESTIGATORMaria Danila, MD, MSPH