New Approach vs Standard Care for Broken Bones Due to Osteoporosis (RESTORE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
No Placebo Group
Trial Summary
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.
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.
12357Is 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.
12567What 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.
12457Will 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.
Eligibility Criteria
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 had a major bone fracture in the past 6 months.
Exclusion Criteria
I have taken specific bone-related medications in the last year.
Participant Groups
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.
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 Clinic Near You
Research locations nearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Setting up an osteoporosis fracture liaison service: background and potential outcomes. [2019]A large evidence base now exists for treatment interventions that will reduce fracture risk. However, the key area of practice now is how to get this evidence base into clinical practice. All health-care systems are subject to financial constraints, and therefore it is important that all areas of clinical practice can demonstrate that they are able to deliver care in a cost-effective manner. It has become increasingly recognized within the area of osteoporosis that treatment interventions should be targeted at patients at the highest absolute risk of fracture in order to maximize the cost-effectiveness of the service. One key subgroup of patients who are at higher absolute fracture risk are patients who present with an incident fracture. Although it has long been recognized that this is a key group to be considered for investigation and intervention, it is also clear that any form of structured care for this group has not been developed. This chapter will review the background and practical aspects of running a fracture liaison service. This service addresses the issue of secondary prevention of fracture while also considering both the absolute risk of fracture and the absolute benefit of the intervention. Issues relating to the background evidence base underpinning the service as well as the practical issues relating to the actual running of a service are discussed. Some of the potential service outcomes are also reviewed.
Fracture Liaison Services in the United Kingdom. [2021]Fracture Liaison Services (FLS) have been demonstrated to be a clinically and cost-effective means of providing secondary preventive care for patients presenting with new fragility fractures. This review summarizes the emergence and widespread adoption of the FLS model in the United Kingdom. Large scale national audits have clearly illustrated the need for FLS by revealing the care gap experienced by the majority of patients who suffer fragility fractures. Since 2003, FLS has featured increasingly more prominently in relevant national professional guidance. During the last 5 years that professional consensus has led to FLS being embedded in government policy on fracture prevention. Quality incentives have been created to encourage hospitals and primary care providers to pro-actively deliver best practice. The strategic approaches taken and lessons learned in the UK may have relevance to quality improvement efforts in other jurisdictions.
Fracture liaison services: improving outcomes for patients with osteoporosis. [2022]Fragility fractures are sentinels of osteoporosis, and as such all patients with low-trauma fractures should be considered for further investigation for osteoporosis and, if confirmed, started on osteoporosis medication. Fracture liaison services (FLSs) with varying models of care are in place to take responsibility for this investigative and treatment process. This review aims to describe outcomes for patients with osteoporotic fragility fractures as part of FLSs. The most intensive service that includes identification, assessment and treatment of patients appears to deliver the best outcomes. This FLS model is associated with reduction in re-fracture risk (hazard ratio [HR] 0.18-0.67 over 2-4 years), reduced mortality (HR 0.65 over 2 years), increased assessment of bone mineral density (relative risk [RR] 2-3), increased treatment initiation (RR 1.5-4.25) and adherence to treatment (65%-88% at 1 year) and is cost-effective. In response to this evidence, key organizations and stakeholders have published guidance and framework to ensure that best practice in FLSs is delivered.
Development of fracture liaison services: What have we learned? [2022]Due to dramatic improvements in life expectancy we are seeing a rapidly growing population of older people. Increasing frailty and susceptibility to fragility fractures are becoming pressing issues for both the individuals that suffer them as well as society, through pressures on health and social care budgets. The success of fracture liaison services, co-ordinated programmes enhancing the management of the fracture, osteoporosis, frailty and falls risk, is undisputed. To achieve optimal outcomes, however, it is important to have a standardisation of design, scope and structure of the service. Experience has taught us that by delegating responsibility for the holistic care of the patient to a trained and adequately resourced professional/team (fracture prevention practitioner) with clear standards against which benchmarking occurs, is the optimal model of delivery. Future challenges include how best to measure the success of services in imparting a reduction in fractures at a local population level as well as how to detect those patients with unmet need who do not uniformly present to health care services, such as those with vertebral fractures. The implementation of fracture liaison services however, is a clear demonstration of how collaboration between health care, social care and charity organisations, among others, has materially improved the health and well-being of the population.
An evaluation of Fracture Liaison Services in the detection and management of osteoporotic fragility fractures: A narrative review. [2019]To evaluate the current evidence for whether Fracture Liaison Services are being utilised effectively in the UK to aid in the prevention of fragility fractures.
Benefits of fracture liaison services (FLS) in four Latin American countries: Brazil, Mexico, Colombia, and Argentina. [2021]Fracture liaison services (FLS) use a multidisciplinary approach to treat patients who have experienced an osteoporotic fracture to reduce the risk of subsequent fractures. To date, there has been minimal FLS implementation in Latin America where fractures continue to be undertreated. This study aims to estimate the number of fractures averted, bed days avoided, and costs saved resulting from universal FLS implementation in Brazil, Mexico, Colombia, and Argentina.
Fracture liaison: A crucial tool in the fight against fragility fracture. [2022]Over the course of the first half of the 21st century the age structure of the human population will have undergone dramatic change, leading to what has been described by the Fragility Fracture Network and the International Osteoporosis Foundation as a new demographic era. In the absence of widespread implementation of systematic approaches to chronic disease management, and prevention and treatment of osteoporosis and fragility fractures in particular, fracture rates among older people will increase significantly by mid-century. The purpose of this narrative review is to characterise the current and projected burden of fragility fractures, evaluate current gaps in delivery of best clinical practice, and summarise the literature on the Fracture Liaison Service (FLS) model of care. A definition of FLS is provided, in addition to findings of systematic reviews and associated meta-analyses conducted to assess the clinical and economic benefits of FLS. Initiatives intended to enable benchmarking of the quality of care provided by FLS are reviewed, including the flagship International Osteoporosis Foundation Capture the Fracture® Programme and examples of national clinical standards for FLS from several countries. The emergence of national clinical registries to facilitate benchmarking against clinical standards is also considered. Finally, a precis is provided of several global and regional initiatives that aim to support changes in healthcare policy to provide funding, at scale, to support widespread implementation of FLS.