Abstract
Q Dr Lewiecki, you are the Osteoporosis Director of the New Mexico Clinical Research & Osteoporosis Center, board member of the US National Osteoporosis Foundation & International Society for Clinical Densitometry, & active clinical researcher & educator. Can you please tell our readers a little about how you became so involved in this field?
There was a watershed period of time in the modern history of osteoporosis about 20 years ago with the convergence of three major events. First, the WHO established a method for diagnosing osteoporosis according to the standard deviation difference between the patient's bone mineral density and that of a young-adult reference population [1]. This came to be known as a T-score, allowing us to diagnose osteoporosis before a fracture occurred rather than after. Second, alendronate received regulatory approval for treating osteoporosis, launching a new era of treatment options and initiating a great deal of public interest in osteoporosis. And third, bone mineral density testing with dual energy x-ray absorptiometry (DXA) became more widely available and affordable for use in clinical practice, allowing the recognition of more patients at risk for fracture. For all of these reasons, my personal interest in DXA quality, osteoporosis patient care and clinical trials of medications to treat osteoporosis took off and has been accelerating ever since.
Q I would like to focus today on secondary fracture prevention – can you provide a little background information on this topic?
A low-trauma fracture (a “bone attack”) is a sentinel event that should trigger appropriate clinical attention directed to reducing the risk of future fractures, just as a ‘heart attack’ is usually followed by efforts to reduce the risk of future heart attacks. This is an important women's health issue, since most of these fractures occur in women. Fractures are associated with significant morbidity and mortality, as well as an increased risk of future fractures, especially in the first few years following the initial fracture. Yet, most patients with fractures are currently not being evaluated and treated as recommended by numerous clinical practice guidelines. A recent study found that only about 20% of patients with hip fractures receive any sort of osteoporosis care when discharged from the hospital [2]. This represents a dismal failure of post-fracture care that is in large part due to lack of ‘ownership’ of osteoporosis by any single medical specialty. To address the osteoporosis treatment gap, much clinical attention has recently been directed to finding more effective ways to reduce the risk of fracture after an initial fracture.
Q Can you give our readers a brief explanation of strategies for developing a Fracture Liaison Service campaign, such as ‘Capture the Fracture’ & ‘Fracture Prevention Central’?
Fracture Liaison Service (FLS) is an umbrella term for the process of systematically identifying, evaluating and treating patients after a fracture. Since the initiation and continuation of FLS can be a daunting endeavor, some stakeholder organizations have developed resources that provide motivation and methodologies to improve the chance of success. As an example, the International Osteoporosis Foundation has Capture the Fracture [3], which aims to support the implementation of FLS worldwide by providing implementation guides, standards of post-fracture care with a grading system for measuring success, mechanisms for sharing FLS experiences, national toolkits and a library of relevant scientific publications. In the USA, the National Bone Health Alliance (a public-private partnership of dozens of organizations working with government agency liaisons to improve the bone health of Americans) has Fracture Prevention Central [4], an initiative that has set a goal of reducing fractures in the USA by 20% by the year 2020 (‘20/20’ vision). An important component of the US strategy is the development of a suite of software applications to support FLS. The tools provided by these programs and others are continuing to evolve as more knowledge is acquired, with most facilities customizing their features according to local needs. Some hospitals and outpatient centers are already using these services and many more are expected to follow in the near future.
Q How does an FLS work? What are its main benefits over conventional care of fracture patients?
FLS can be effective in the hospital or outpatient setting. The key feature of an FLS is a dedicated coordinator, often a clinical nurse specialist, who facilitates all aspects of a post-fracture care protocol. The steps of care include identification of the patient presenting with a fracture and maintaining a database of these patients to track and document progress of evaluation and treatment. The coordinator may be empowered to educate patients, assess the risk of falls, order laboratory tests and DXA, start or recommend treatment and follow-up with the patient and physicians to assure that protocol milestones have been met. Robust software applications, such as those being developed by the National Bone Health Alliance, are essential for optimizing the efficiency of the coordinator's activities and providing automated documentation of meeting quality standards established by payers of healthcare services. With FLS, more patients are appropriately evaluated and treated, reducing the risk of future fractures and saving money by decreasing fracture-related healthcare expenses compared with conventional care.
Q What are the main obstacles associated with the implementation of an FLS?
It is regrettable that there are barriers to FLS at many healthcare facilities, although these may be overcome through the passion, perseverance and persuasiveness of a local FLS ‘champion’ – often a physician with a deep concern for caring for patients with osteoporosis. Barriers include ‘turf battles’ by physicians over control of patient care, fear of lost income for individual physicians or facilities with fragmented delivery of healthcare, concern regarding funding of the salary for the FLS coordinator and FLS infrastructure, and institutional unease that the return on investment may not justify the cost of supporting FLS. Some patients who could benefit from osteoporosis treatment may not be willing to accept it due to poor understanding of the risk of fractures, the consequences of fractures and the balance of expected benefits versus possible adverse effects of treatment. The greatest motivator for hospital systems to overcome these barriers, aside from providing better patient care, may be avoidance of financial penalties and collection of financial rewards for demonstration of achieving targets of quality care after a fracture.
Q The ‘Capture the Fracture’ campaign has created a Best Practice Framework for FLS to work within & toward – how can FLS in countries with disparate healthcare services be assessed within a common framework?
The Fracture Best Practice Framework is a set of 13 FLS standards in the ‘Capture the Fracture’ program. They include patient identification, evaluation, treatment, timing of post-fracture assessment, falls prevention services, communication strategies and maintenance of a patient database. Since some of the standards are essential and some are aspirational, each is weighted for importance on a scale of 1 to 3 (3 being most important). Depending on the level of achievement for each standard, a score of 1, 2 or 3 (3 being best) is assigned. The weight for each standard is then multiplied by the level of achievement and the results are summed to calculate a total achievement level. Depending on this value, a rating of unclassified, bronze, silver or gold is assigned. This process creates competition for excellence among FLS programs, provides motivation for improvement, allows for feedback on areas that need improvement and compares FLS programs in disparate healthcare settings.
Q What differences in diagnosis & treatment of fracture do you hope to see in the coming years as a result of the implementation of FLS worldwide?
The FLS model of care addresses osteoporosis treatment from the public health perspective rather than leaving it to chance that individual physicians will intervene. The hope is that global adoption of FLS will result in the evaluation and appropriate treatment of more post-fracture patients. If this is successful as intended, there will be a reduction in fracture-related morbidity, mortality and healthcare expenses. In this time of limited healthcare resources and competing healthcare priorities, FLS may allow for more healthcare resources to be directed to other areas of need. I support the US National Bone Health Alliance 20/20 goal and would like to see it applied to other nations as well.
Q What direction do you see the field of osteoporosis & fractures in general taking over the coming years? Which areas of research require more attention in your opinion?
The current paradigm, which is a good one, is to identify and treat patients at high risk for fracture, particularly patients who have already had a fracture, in order to reduce the risk of future fractures. However, I am concerned that this trend may lead to undervaluation of osteoporosis prevention, which I believe still has an important role in patient care. Non pharmacological measures with skeletal benefits for all patients include regular weight-bearing and muscle-strengthening physical activity, adequate intake of calcium and vitamin D, avoidance of smoking, limitation of alcoholic beverages and prevention of falls. I would like to see more investigation into interventions to mitigate the downward spiral involving loss of muscle mass and strength (sarcopenia), reduced vitality and increase in fracture risk that occurs with aging and disabilities. Pharmacological treatments for sarcopenia are currently in clinical trials [5], and more are likely to follow. Whole-body vibration has not yet been convincingly demonstrated to provide skeletal benefits, although more investigation may be needed to identify a specific target population that might benefit and determine whether there is an optimal amplitude, frequency and duration of vibration. The future of treatments to improve bone strength appears to be with osteoanabolic (bone-forming) agents that target molecular regulators of bone remodeling, single compounds or drug combinations that uncouple bone resorption and formation in a beneficial way and new drug delivery systems (e.g., transdermal or oral administration of drugs that must otherwise be given by injection). I look forward to a bright future for the care of osteoporosis.
Disclaimer
The opinions expressed in this interview are those of the interviewees and do not necessarily reflect the views of Future Medicine Ltd.
Financial & competing interests disclosure
EM Lewiecki has received research grant support from Amgen, Eli Lily and Merck; and consulting fees from Amgen, Eli Lily, Merck, Radius Health, AgNovos Healthcare, Theranova, Alexion, NPS and AbbVie. EM Lewiecki has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.