Actively Recruiting
RESTORE: Reducing Future Fractures and Improving Outcomes of Fragility Fracture
Led by University of Alabama at Birmingham · Updated on 2026-05-05
2634
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two approaches to improve care for people aged 50 and older who have recently had a fragility fracture, a break in bones caused by osteoporosis. The study, called RESTORE, compares an Augmented-Fracture Liaison Service where patient navigators help guide patients to bone health specialists, to Enhanced Usual Care, which provides education materials and encourages follow-up with primary care doctors. The study also examines how factors like age, race, ethnicity, sex, poverty, and geographic region affect the success of these strategies. Participants are randomly assigned to one of two groups. One group receives mailed education materials and encouragement to see their primary care provider. The other group receives the same materials plus contact from a patient navigator who assists in scheduling and attending appointments with a bone health clinician. This study uses a single-blind design and follows participants for at least 24 months after randomization. During the study, participants will be monitored for any new fractures occurring within 24 months. Researchers will collect information on participants' health outcomes and adherence to recommended care. The trial requires participants to have had a recent fragility fracture and a regular primary care provider and to remain near the study site for follow-up. Safety and progress will be observed throughout the study, which is led by the University of Alabama at Birmingham.
CONDITIONS
Brief Title
RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years and older (no upper age limit)
- Had a primary fragility fracture (hip/femur, pelvis, clinical spine, humerus, wrist) within the last 12 months
- Have a regular primary care provider
- Have a mailing address
- Plan to remain geographically near the study site for several months
You will not qualify if you...
- Taken bone medications like risedronate, alendronate, zoledronic acid, ibandronate, pamidronate, denosumab, romozosumab, abaloparatide, teriparatide, parathyroid hormone, raloxifene, bazedoxifene-conjugated estrogen, or calcitonin in the past 12 months
- Have chronic kidney disease stage 4 or 5 or are on dialysis
- Have multiple myeloma, Addison's disease, or adrenal insufficiency
- Are enrolled in hospice care
- Have had or expect to have a solid organ or bone marrow transplant
- Have a metabolic bone disease other than osteoporosis
- Have fractures caused by severe trauma or cancer/infection
- Have a scheduled appointment with a bone health specialist
- Are unable to consent on their own due to cognitive impairment
- Are currently enrolled in another medication study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 months post randomization
Participants receive behavioral interventions including education materials and guidance from patient navigators to facilitate bone health care.
Trial Site Locations
Total: 23 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
UAMS Health
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
4
University of Florida- Gainesville
Gainesville, Florida, United States, 32611
Actively Recruiting
5
University of Florida- Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
8
University of Illinois Chicago (UIC), UI Health
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Loyola University Chicago
Maywood, Illinois, United States, 60153
Actively Recruiting
10
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Allina Health Orthopedics/NorthStar Trauma Network
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
12
Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65212
Actively Recruiting
13
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
14
University of Nebraska Medical Center
Omaha, Nebraska, United States, 69198
Actively Recruiting
15
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
16
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
17
Montefiore Medical Center
The Bronx, New York, United States, 104661
Actively Recruiting
18
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
19
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
20
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
21
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
22
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
23
UT Health Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elizabeth M Dye, MSN
P
Paolo Rusconi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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