RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE

Not Applicable

Recruiting

• Conditions: Osteoporotic Fractures; Osteoporosis
• Interventions: Behavioral: Augmented-Fracture Liaison Service Arm; Behavioral: Enhanced Usual Care Arm

• Registration Number: NCT06455085
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-12
• Study Start: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2029-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2634

Inclusion Criteria

• Age 50 years and older (no upper age limit)
• Sustained a primary fragility fracture (hip/femur/pelvis, clinical spine, humerus, wrist/forearm) in the last 6 months
• Participant must self-identify a regular primary care provider (PCP)

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)
  • Miacalcin (calcitonin)

• Diagnosis of the following medical conditions

  • CKD stage 4 and above
  • Paget's disease
  • Multiple myeloma
  • Osteomalacia
  • Addison's disease
  • Adrenal insufficiency
  • Enrolled hospice care
  • Solid organ transplant
  • Bone marrow transplant

• Fractures resulting from severe trauma

• Scheduled appointment with a bone health clinician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Augmented-Fracture Liaison Service Arm	Augmented-Fracture Liaison Service Arm	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.
Enhanced Usual Care Arm	Enhanced Usual Care Arm	Participants will be mailed education materials and encouraged to follow up with their primary care physician.

Primary Outcome Measures

Name	Time	Method
Incidence of subsequent fracture	24 months post randomization	Incidence of fracture 24 months post randomization

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States