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Behavioral Intervention

New Approach vs Standard Care for Broken Bones Due to Osteoporosis (RESTORE Trial)

N/A
Waitlist Available
Led By Maria Danila, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Exposure to specific 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post randomization
Awards & highlights

Summary

"This trial is comparing a new approach called Augmented-FLS, where patients are contacted by a patient navigator and referred to a bone health provider, to the standard approach called Enhanced Usual Care,

Who is the study for?
The RESTORE trial is for individuals with osteoporosis or those who have recently experienced bone fractures due to the condition. It's open to a diverse group regardless of age, race, ethnicity, sex, poverty level, and location. However, specific details on who can't participate are not provided.
What is being tested?
This study compares two approaches: Augmented-Fracture Liaison Service (FLS) involving a patient navigator and referrals to bone health specialists versus Enhanced Usual Care that focuses on educating patients and primary care providers about bone health.
What are the potential side effects?
Since this trial involves service-based interventions rather than medications or invasive procedures, typical drug-related side effects are not expected. Any potential side effects would likely be related to the individual's response to receiving additional healthcare guidance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.
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I have had a major bone fracture in the past 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken specific bone-related medications in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of subsequent fracture

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Augmented-Fracture Liaison Service ArmExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual Care ArmActive Control1 Intervention
Participants will be mailed education materials and encouraged to follow up with their primary care physician.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,285,286 Total Patients Enrolled
17 Trials studying Osteoporosis
581,054 Patients Enrolled for Osteoporosis
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,989,516 Total Patients Enrolled
1 Trials studying Osteoporosis
3,780 Patients Enrolled for Osteoporosis
Maria Danila, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
~1756 spots leftby Jun 2029
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