RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Osteoporosis; Osteoporotic Fractures; Fragility Fracture

Treatments: Behavioral: Augmented-Fracture Liaison Service Arm; Behavioral: Enhanced Usual Care Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06455085

OFP-2022C3-30386 (Other Grant/Funding Number)

IRB-300012444

Details and patient eligibility

About

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.

Enrollment: 2,634 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,634 participants in 2 patient groups

Enhanced Usual Care Arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Usual Care Arm

Augmented-Fracture Liaison Service Arm

Experimental group

Description:

Participants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment.

Treatment:

Behavioral: Augmented-Fracture Liaison Service Arm