New Approach vs Standard Care for Broken Bones Due to Osteoporosis

(RESTORE Trial)

Overseen By Kate Bryan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Bisphosphonates, Denosumab, Romozosumab, others

Disqualifiers: CKD stage 4, Paget's, Myeloma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

2634 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different care methods for individuals with osteoporosis-related fractures. The Augmented-Fracture Liaison Service Arm provides participants with educational materials and check-ins from a patient navigator, who assists in scheduling appointments with bone health specialists. The Enhanced Usual Care Arm offers educational materials and encourages participants to follow up with their primary care doctor. This trial targets individuals aged 50 and older who have experienced a fragility fracture (a break from a fall or minor injury) in the past six months and have a regular primary care doctor. As an unphased trial, it allows participants to contribute to valuable research that could enhance osteoporosis care strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken certain bone-related medications in the past 12 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that fracture liaison services (FLS) are generally safe for people with osteoporosis. These services help prevent additional fractures by ensuring patients receive appropriate care and follow-up. A patient navigator connects patients with bone health experts as part of this service.

Studies have found no evidence that FLS causes serious side effects. The main goal is to improve bone health and reduce the risk of future fractures. Since this service emphasizes coordination and support rather than medication, typical drug-related side effects are not a concern.

The trial tests the Augmented-Fracture Liaison Service, which provides more active patient support than standard care. This includes education and follow-up with primary care doctors. Both methods are non-invasive, and research has not reported any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more comprehensive approach to managing osteoporosis-related fractures. Unlike traditional care, which typically involves mailing educational materials and recommending follow-ups with a primary care physician, this trial introduces an Augmented-Fracture Liaison Service. This new method not only provides educational materials but also includes patient navigators who actively guide participants to book appointments with Bone Health Clinicians. This hands-on guidance could potentially streamline care and improve outcomes for patients by ensuring timely and specialized attention, which is a step up from the usual care approach.

What evidence suggests that this trial's treatments could be effective for broken bones due to osteoporosis?

Research has shown that the Augmented-Fracture Liaison Service (FLS), which participants in this trial may receive, can help lower the risk of additional fractures in people with osteoporosis. One study found that individuals who received FLS care experienced fewer new fractures than those who did not. The FLS program provides advice on diet and lifestyle to strengthen bones and includes patient navigators who assist in scheduling appointments with bone health specialists. Overall, evidence suggests that FLS effectively improves bone health and prevents future fractures. Meanwhile, participants in the Enhanced Usual Care Arm will receive educational materials and are encouraged to follow up with their primary care physician. ^{1 2 3 6 7}

Who Is on the Research Team?

Kenneth Saag, MD

Principal Investigator

University of Alabama at Birmingham

Maria Danila, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 50 years old or older.

I have a primary care doctor I see regularly.

I have had a major bone fracture in the past 6 months.

Exclusion Criteria

I have taken specific bone-related medications in the last year.

I have a specific condition like CKD stage 4+, Paget's, or a history of thyroid issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Augmented-FLS with patient navigator support or Enhanced Usual Care with educational materials

24 months

Follow-up

Participants are monitored for incidence of subsequent fractures and other outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Augmented-Fracture Liaison Service Arm
• Enhanced Usual Care Arm

Trial Overview

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.

How Is the Trial Designed?

Group I: Augmented-Fracture Liaison Service Arm Experimental Treatment 1 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 Arm Active Control 1 Intervention

Participants will be mailed education materials and encouraged to follow up with their primary care physician.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Targeting treatment interventions for osteoporosis at patients with the highest risk of fracture, particularly those presenting with an incident fracture, is crucial for maximizing cost-effectiveness in clinical practice.

The chapter discusses the establishment of a fracture liaison service aimed at secondary prevention of fractures, emphasizing the need for structured care to improve patient outcomes and address both fracture risk and intervention benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting up an osteoporosis fracture liaison service: background and potential outcomes. Gallacher, SJ.[2019]

Fracture Liaison Services in the UK are underutilized, with many patients not receiving necessary risk assessments or treatments for preventing future fragility fractures, despite evidence that targeted treatment can significantly reduce fracture risk.

Improving and standardizing the reporting of vertebral fractures is crucial for identifying at-risk patients, and while these services are cost-effective and beneficial, they are not universally available across NHS providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of Fracture Liaison Services in the detection and management of osteoporotic fragility fractures: A narrative review. Eccles, E., Thompson, JD., Roddam, H.[2019]

Fracture Liaison Services (FLS) have proven to be an effective and cost-efficient way to provide secondary preventive care for patients with fragility fractures, addressing a significant care gap identified in national audits.

Since their introduction in 2003, FLS have been increasingly integrated into UK government policy and professional guidelines, promoting proactive fracture prevention and encouraging hospitals to adopt best practices through quality incentives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fracture Liaison Services in the United Kingdom. Mitchell, PJ.[2021]

Fracture liaison services (FLSs) that provide comprehensive care, including identification, assessment, and treatment of osteoporosis, significantly reduce the risk of re-fractures and mortality in patients with osteoporotic fragility fractures, with hazard ratios indicating a 33-82% lower risk of re-fractures and a 35% lower risk of mortality over 2 years.

These intensive FLS models also lead to higher rates of bone mineral density assessments and treatment initiation, with adherence to osteoporosis treatment reaching 65-88% within a year, demonstrating both efficacy and cost-effectiveness in managing osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fracture liaison services: improving outcomes for patients with osteoporosis. Walters, S., Khan, T., Ong, T., et al.[2022]

Implementing fracture liaison services (FLS) in Brazil, Mexico, Colombia, and Argentina could prevent approximately 31,400 osteoporotic fractures and save around 58.4 million USD in healthcare costs in just one year (2019).

The study estimates that FLS could also avoid nearly 292,281 hospital bed days across these countries, highlighting the potential for improved patient outcomes and reduced healthcare burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of fracture liaison services (FLS) in four Latin American countries: Brazil, Mexico, Colombia, and Argentina. Aziziyeh, R., Perlaza, JG., Saleem, N., et al.[2021]

The aging population is expected to lead to a significant increase in fragility fractures among older adults by mid-century, highlighting the urgent need for effective chronic disease management and osteoporosis prevention strategies.

The Fracture Liaison Service (FLS) model has been shown to provide clinical and economic benefits in managing fragility fractures, and initiatives like the International Osteoporosis Foundation's Capture the Fracture® Programme aim to improve the quality of care and support widespread implementation of FLS globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fracture liaison: A crucial tool in the fight against fragility fracture. Mitchell, PJ.[2022]

Fracture liaison services have proven effective in managing fractures, osteoporosis, and falls risk among the growing population of older adults, emphasizing the need for standardized service design and trained professionals for optimal care.

Future challenges include measuring the success of these services in reducing fractures and identifying patients with unmet needs, such as those with undiagnosed vertebral fractures, highlighting the importance of collaboration across healthcare sectors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of fracture liaison services: What have we learned? Shipman, KE., Doyle, A., Arden, H., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11211169/

Effectiveness of fracture liaison service in reducing the risk ...

This review found clinically important moderate certainty evidence showing that the risk of secondary fragility fracture was lower in the FLS intervention at ≥ ...

2.

uab.edu

uab.edu/news/health-medicine/osteoporosis-uab-led-study-approved-for-a-13-9-million-award-to-investigate-prevention-of-bone-fractures

Health & Medicine | UAB News

“A Fracture Liaison Service, or FLS, is a post-fracture care approach that includes patient education on diet and lifestyle to improve bone ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06455085

RESTORE: REducing Future fractureS and Improving ...

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 ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0188440924001723

Incidence of Secondary Fractures After Implementation ...

The efficacy of FLS has been measured by a variety of outcomes, such as changes in bone mineral density (BMD), screening rates, fall prevention, changes in OP ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8376729/

The impact of fracture liaison services on subsequent ...

Studies were included if they reported the effectiveness of FLS care in terms of subsequent fractures and/or mortality compared to no-FLS care.

6.

sicot-j.org

sicot-j.org/10.1051/sicotj/2025035

Osteoporotic vertebral fractures: an update

Successful management of osteoporotic vertebral fractures entails alleviating pain, early restoration of mobility, and secondary fracture prevention. Prevention ...

7.

withpower.com

withpower.com/trial/phase-osteoporosis-8-2024-fc3ec

New Approach vs Standard Care for Broken Bones Due to ...

Fracture Liaison Services (FLS) have been shown to be effective in preventing further fractures in patients with osteoporosis by providing coordinated care and ...