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
232 weeks
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
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.
CONDITIONS
Official 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)
- 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
You will not qualify if you...
- Exposure to specific osteoporosis medications in the prior 12 months, including Actonel, Atelvia, Fosamax, Binosto, Reclast, Zometa, Aclasta, Boniva, Bondronat, Aredia, Prolia, Evenity, Tymlos, Forteo, Natpara, Evista, Duavee, and Miacalcin
- Diagnosis of chronic kidney disease stage 4 or 5, or on dialysis
- Multiple myeloma
- Addison's disease or adrenal insufficiency
- Enrolled in hospice care
- Solid organ transplant recipient or expecting a transplant
- Bone marrow transplant recipient
- History of metabolic bone diseases other than osteoporosis, such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease
- Fractures caused by severe trauma (e.g., motor vehicle accidents, falls from 2 feet or higher)
- Pathologic fractures due to cancer or infection
- Scheduled appointment with a bone health specialist
- Unable to consent independently due to cognitive impairment or dementia
- Currently enrolled in another research study that requires taking medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
P
Paolo Rusconi, PhD
CONTACT
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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