RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Conditions

• Fragility Fracture
• Osteoporosis
• Osteoporotic Fractures

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Augmented-Fracture Liaison Service Arm — BEHAVIORAL
  Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
• Enhanced Usual Care Arm — BEHAVIORAL
  Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Study Details

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.

Key Dates

Start date

Dec 16, 2024

Status verified

Jan 2026

Primary completion

Jun 1, 2029

Completion

Jun 1, 2029

Study Design

Enrollment

2,634 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Enhanced Usual Care Arm
  Participants will be mailed education materials and encouraged to follow up with their primary care physician.
• Experimental: 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.

Primary Outcome Measure

Incidence of subsequent fracture [ Time Frame: 24 months post randomization ]

Central Contacts

• Elizabeth M Dye, MSN
  205-996-5025
  [email protected]
• Paolo Rusconi, PhD
  205-975-2405
  [email protected]

Locations (23)

Find similar trials in Birmingham, AL

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