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?

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.

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 the Fracture Liaison Service (FLS) safe for treating osteoporosis-related fractures?

The Fracture Liaison Service (FLS) is a well-established approach used globally to manage and prevent fractures in people with osteoporosis. It is considered safe and effective, focusing on reducing the risk of future fractures through coordinated care. ^{1 2 3 4 5}

How does the Augmented-Fracture Liaison Service Arm treatment differ from standard care for osteoporosis-related fractures?

The Augmented-Fracture Liaison Service Arm is unique because it focuses on a systematic approach to managing osteoporosis and preventing future fractures by identifying, assessing, and treating patients with fragility fractures. This model is associated with better outcomes, such as reduced risk of re-fracture and mortality, and increased adherence to osteoporosis treatment, making it more effective than standard care. ^{1 2 4 5 6}

What data supports the effectiveness of the treatment Augmented-Fracture Liaison Service Arm for broken bones due to osteoporosis?

Fracture Liaison Services (FLS) have been shown to be effective in preventing further fractures in patients with osteoporosis by providing coordinated care and management, which has been successfully implemented in the UK and other regions to improve patient outcomes and reduce healthcare costs. ^{1 2 4 5 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

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 (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]

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 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]

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]

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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Fracture Liaison Services in the United Kingdom. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of Fracture Liaison Services in the detection and management of osteoporotic fragility fractures: A narrative review. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Development of fracture liaison services: What have we learned? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Benefits of fracture liaison services (FLS) in four Latin American countries: Brazil, Mexico, Colombia, and Argentina. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Fracture liaison services: improving outcomes for patients with osteoporosis. [2022]