Looming increase in fragility fractures demands improved preventative care

Two million fractures per year are attributed to osteoporosis, and with an increasing elderly population, this number is expected to double by 2040. Despite these numbers and the increasing economic burden of these fractures, published studies show that only 20% of patients with osteoporosis are receiving proper treatment and prevention measures.

Fracture Liaison Services and other fracture prevention programs are working to bend the curve on the fragility fracture rate in the elderly population.

“We are trying to apply the models that have been shown to be effective and reduce the numbers of fragility fractures by between 20% and 40%,” Richard M. Dell, MD, an orthopedic surgeon at Kaiser Permanente in Downey, Calif., told Orthopedics Today.

According to the National Osteoporosis Foundation (NOF), about 52 million Americans have osteoporosis or low bone mass (osteopenia), which places them at increased risk for osteoporosis.

“The problem is that as people get older, their risk for a hip fracture doubles roughly every 5 years,” Dell said.

Data have suggested that approximately one in two women and one in four men aged 50 years or older will break a bone due to osteoporosis. “There are almost two times as many hip fractures as there are new cases of breast cancer diagnosed each year,” Julie A. Switzer, MD, director of geriatric trauma at Regions Hospital in St. Paul, Minn., and assistant professor at the University of Minnesota, told Orthopedics Today.

Burge and colleagues found there were more than 2 million osteoporosis-related fractures costing more than $19 billion in 2005. They projected that by 2025, annual fractures and costs will increase by almost 50%, with the most rapid growth estimated for people aged 65 years to 74 years — an increase of more than 87%.

According to the Administration on Aging, the population of those age 65 years or older was 39.6 million in 2009. By 2030, this figure is estimated to reach 72.1 million.

The consequences of these fragility fractures are significant. “Mortality rates for those who sustain an osteoporotic-related fracture are 81% higher in women and 105% higher in men than [patients with] non-osteoporotic fractures,” said Kenneth A. Egol, MD, professor and vice chairman of the Department of Orthopedic Surgery at the Hospital for Joint Diseases and NYU Medical Center. “Having a fragility fracture significantly increases mortality risk and that usually stays elevated for a period of time — up to 5 years.”

After a hip fracture, the 1-year mortality rate is 25% and this number is closer to 30% in men, according to Switzer. “Across the board, morbidity and mortality following hip fracture is much greater in men than in women,” she said. “In other words, 80% of hip fractures occur in women, and 20% occur in men, but if you are one of the men who sustains a hip fracture, you are probably frailer than other men your age.”

Switzer added that sustaining more than one fracture simultaneously also increases the mortality rate.

Data continue to show that few patients who need osteoporosis treatment receive it. In a prospective observational study, Greenspan and colleagues analyzed self-administered questionnaires from 60,393 postmenopausal women aged 55 years or older and found that 17% of women who reported an incident fracture had started anti-osteoporosis medication.

“Only about 20% of patients who actually have a fragility fracture are identified as having osteoporosis and are then treated,” Dell said.

Prevention of fragility fractures

Pressing the importance of the condition and the need for treatment is often the first step to fracture prevention. “Osteoporosis is a silent disease, and because of that, it is hard to convince patients that they have the disease,” Dell said.

Oftentimes, explaining the 25% increased risk for mortality after a hip fracture or mentioning the lack of independence with a hip fracture will help impress the severity of the condition to patients with osteoporosis. “If I tell patients, if you have a hip fracture, you may end up in a nursing home or dying, that gets their attention,” Dell said.

Patients with osteoporosis need to approach fracture prevention holistically. “A lot of people think, ‘I will just take this pill and it will help prevent the fracture. I do not have to exercise, take vitamins or do a fall prevention class. I can keep smoking.’ That is not the correct way to prevent fractures,” Dell said. “If someone eats a good diet that is rich in calcium and vitamin D and exercises, his chance of falling is drastically reduced.”

“The three things I emphasize, in regard to diet, are getting enough calcium, vitamin D and protein because we know in human, and especially in animal, models that those three nutritional factors make the greatest difference in bone healing,” Switzer said.

According to Thomas A. Einhorn, MD, professor and chairman of orthopedic surgery at Boston University Medical Center, there is still debate about the proper amount of calcium and vitamin D that patients need.

“It is probably in the vicinity of somewhere between 800 units and 1,000 units of vitamin D per day and somewhere between 1,000 mg and 1,500 mg of calcium per day,” he said. “But even if patients are replete with calcium and vitamin D, that alone does not protect them from fractures.”

He also stressed the importance of monitoring at-risk patients. “Women should have bone mineral density tests performed at the time of menopause to see if they are at risk for developing osteoporosis,” Einhorn said. “There needs to be an awareness in men as well.”

In addition, patients need to make their homes fracture prevention-ready by removing obstacles throughout the house, installing safety rails in the bathroom and using a nightlight, Dell said.

Switzer emphasized a focus on fall prevention and balance. “There is some good evidence that exercises like tai chi, which focuses on balance, can help decrease the rate of fragility fractures,” she said.

According to Einhorn, patients also need to ensure they have good vision and eye health. “They need glasses, and they need to try and arrange their environment so that there are not books to slip and fall on, for example, or wires crossed where people may walk,” he said.

Einhorn also suggested primary care physicians review patients’ medications and dosages to ensure they are not “overmedicated, drowsy or unable to respond if they were to be in a situation where they might fall.”

Pharmacotherapy, such as bisphosphonate use, has been shown to reduce the hip fracture rate by 40% to 60%, Dell said.

Postmenopausal women with a dual X-ray absorptiometry (DXA) scan with a T score of less than -2.5 or those who have had a previous fragility fracture should be prescribed a pharmacologic agent, Egol said.

“We also use the FRAX tool and initiate treatment based on the NOF guidelines of a 10-year hip fracture risk of 3% or greater or a 10-year major fracture (proximal, humerus, wrist, hip or spine) risk of 20% or greater,” Dell said.

“Bisphosphonates have, for about 20 years, been the mainstay among various classes of anti-osteoporotic drugs,” Egol said. “In the last 20 years, we have seen a significant decrease in the rate of fragility fractures.”

“These medications have decreased the likelihood of an individual sustaining a fragility fracture, they have helped increase the strength of the skeleton, and there are good data to show that they decrease the risk for hip fracture, compression fracture and distal radius fracture — the three primary models that have been studied,” Switzer said.

With any pharmacologic agent, there are risks — such as the risk for atypical femur fractures with bisphosphonate therapy, for example; however, many patients believe osteoporosis medications cause serious side-effects more often than data show. “These serious side effects, like atypical femur fractures, are unlikely to occur, whereas it is not that uncommon to have a hip fracture,” Dell said. “You have to weigh the risks and benefits.”

“Now that we understand a little bit more about these risks, we are limiting the amount of time we keep patients on this medication,” Egol said.

However, “study after study shows that about 20% of people who need the medication are getting the medication,” Dell said. “We need to get the medication to the right people and make sure they take it correctly.”

One way to improve patient compliance of medication is to change the medication delivery mode, Einhorn said. “For example, if a bisphosphonate is given once a week or twice a month by mouth, that is something that patients can easily forget,” he said. “On the other hand, one of the bisphosphonates is given by a yearly intravenous injection, and that may be a better way to go because patients will be seeing their doctor once a year anyway.”

In the treatment of osteoporosis-related fractures, patients often have the best outcomes when surgery is performed within 16 hours to 24 hours after the injury. “It requires optimal surgery and mobilizing the patient as quickly as possible,” Dell said. “If you do that, there is a good chance the patient will do significantly better than if you do the standard of care. You need to optimize your patients before they get into surgery.”

In addition, anticoagulation is important for the prevention of pulmonary embolism or deep vein thrombosis. Dell and his colleagues use a spinal or epidural anesthesia for elderly patients to decrease the risk of blood clots and to prevent other complications associated with the use of general anesthesia. Switzer pointed out that few studies have done head-to-head comparisons of general and regional anesthesia for these patients. “However, it seems as though there is not only a trend in practice, but probably less cognitive dysfunction afterward when using regional anesthesia,” she said.

“It is important that you get pre-anesthetic clearance on these patients, that everyone is aware of all of the patients’ medical problems and that patients are optimized as quickly as possible before they come in for their surgeries,” Dell said.

Another consideration in surgical treatment for osteoporosis-related fractures is handling the skeleton appropriately. “This includes using the appropriate devices and knowing how to use intramedullary devices, as well as knowing how to use locking plates at the appropriate time and in the appropriate place,” Einhorn said.

Research has demonstrated a 30% compliance rate for anti-osteoporosis medication among older people, according to Switzer. “One of the things unique to the elderly is that, following their fracture admission, they might not be going to their home and living in a stable situation,” she said. “They may be discharged from the hospital to a transitional care unit and/or they may go to a nursing home, and prescription of medication in those settings can be more difficult, in part because of cost to the facility for administration of some of the anti-osteoporosis medications.”

In addition, whenever there is a transition of care — from home to the hospital, from the hospital to the transitional care unit, from the transitional care unit to the home — there is an increased chance for a mistake or miss in medication. “There is a reasonable chance that an osteoporosis medication would be something that might be left off the list of discharge medications,” Switzer said.

According to Egol, the low compliance rates are also due to patients’ reluctance to take additional medications. “There is a lack of patient knowledge about osteoporosis, there is a lack of faith that the intervention will make a difference and there is a lack of motivation,” he said. “Some studies have shown that home health-aides and family involvement increase compliance with some of these regimens.”

Fracture Liaison Services

With the projected increases in osteoporosis-related fractures and the current low rates of treatment, many are calling for greater partnerships among specialties, such as geriatricians, primary care physicians, nursing and care management, as well as greater awareness and proactive steps for prevention.

Several organizations, including the American Orthopaedic Association (AOA), the National Geriatric Fracture Society, the National Bone Health Alliance, the National Osteoporosis Foundation and the Fragility Fracture Network, are working toward prevention of osteoporosis-related fractures. In a 2012 article, the American Society for Bone and Mineral Research (ASBMR) Task Force on Secondary Fracture Prevention called for a cooperative approach and national central clearinghouses for secondary fracture prevention initiatives to align and streamline efforts.

The ASBMR Task Force, in that same article, summarized evidence for various forms of the Fracture Liaison Service as “the most effective intervention for secondary fracture prevention.” Through the Fracture Liaison Service program, one individual — a nurse practitioner, physician’s assistant or primary care doctor, for example — is accountable for coordinating care regarding a patient with osteoporosis. “Someone has to communicate with the orthopedic surgeon, the primary care doctor, the specialist and the patient and get everybody on board to acknowledge that the person has osteoporosis and that they are going to manage that osteoporosis to prevent future fractures,” Dell said.

AOA’s Own the Bone initiative, launched in 2009, offers a turnkey system for hospitals, medical centers and practices to establish a Fracture Liaison Service. According to the initiative’s website, 43 states had institutions that implemented an Own the Bone program as of May 2013. “About 400 institutions have implemented it,” said Marc F. Swiontkowski, MD, professor in the Department of Orthopaedic Surgery at the University of Minnesota and a member of the Own the Bone advisory board. “It needs a physician leader and an institution to drive the program, but the program and all its tools are available to institutions that want to do the right thing for these patients.”

According to Swiontkowski, Own the Bone provides a web-based patient registry, patient education materials as well as sample letters for the primary care doctor and the patient concerning follow-up DXA scans.

In 2002, Kaiser Permanente Southern California implemented the Healthy Bones Model of Care, which was based partially on the Fracture Liaison Service program. The Geisinger Clinic, Cleveland Clinic and Mayo Clinic have all adopted similar programs.

Specifically at Kaiser, each day, case managers and clinicians use information technology systems to identify enrollees with gaps in care and then use this information to proactively contact those in need of screening to schedule a bone density scan. Once the results are interpreted, patients who require additional services receive education on osteoporosis, including fall prevention classes and home safety recommendations, as well as a prescription for medication to improve bone density and referrals for additional support. According to a report from the Department of Health and Human Services, in 2011, this program at Kaiser led to a 473.7% increase in the annual number of DXA scans, a 49% reduction in hip fractures, more than 350 lives saved and an estimated $50 million reduction in the cost of treatment.

Ideally, the model begins with patients who have already had a fracture because they are most likely to refracture. “The cost savings from that type of model can be reinvested and then address primary fracture prevention, meaning looking for people who are at high risk but have not had their first fracture yet,” Dell said.

“If we implemented this model across the United States, hopefully we would see the same thing as we did at Kaiser where we basically held steady year after year on the absolute number of hip fractures,” he said. “In fact, we saw a reduction in the absolute number of hip fractures at the same time our population was getting older.”

The National Bone Health Alliance is leading the national effort to get the word out about the effectiveness of the Fracture Liaison Service and its 2020 vision of a 20% reduction in the fracture rate, according to Dell. The alliance’s program 2Million2Many addresses the fact that roughly 2 million patients per year will have a fragility fracture and is working with the pharmaceutical industry, the public and CMS to raise awareness and implement these models of care nationally.

Dell said he hopes the health care community will put into action the measures that have been shown to work. “You do not need a new program, you do not need a new drug, you do not need a new therapy; you just have to do the things that you know work, because right now, we are only doing the things that work 20% of the time,” he said. “I would like to see as close to 100% of the time as possible, instituting evidence-based medicine best practices because those best practices have been shown to reduce the fracture rate by nearly 50%. That is where the major effort should be.” – by Tina DiMarcantonio

What are some ways to ensure patient compliance with fragility fracture prevention protocols?

Fracture liaison teams help ensure compliance

From an orthopedic view, fragility fracture prevention should be addressed at the time of an initial fracture. The data strongly predict a two-fold to five-fold increased risk for further fractures compared with the general population in individuals with one fragility fracture. The reasons for poor response to treatment rest with a combination of factors: lack of recognition of the fracture risk by both the patient and his or her family; failure of the fracture team in supporting treatment; reliance on the family medical doctor to recognize the need and initiate treatment; and resistance of the fracture team to take this responsibility due to lack of training and perceived disinterest. As a consequence, only 25% of patients with a hip fracture have their underlying osteoporosis addressed.

Recent studies have clearly demonstrated that the key moment to initiate treatment is during the perioperative window, and the responsible team is the fracture group. The most successful programs create a fracture liaison team headed by a mixture of physicians, all with an interest in osteoporosis. The team often includes endocrinologists, rheumatologists, gerontologists, physiatrists and orthopedists. This team utilizes nurse practitioners to educate the family and correct the calcium and vitamin D in the hospital. Once these levels are therapeutic, the nurse places the patient directly on the appropriate osteoporotic medical agent based on algorithms established by the medical team. This process is performed within 6 weeks to 12 weeks following the fracture. Once established, this treatment program is then handed off to the primary medical doctor to maintain. The key elements are education of the patient and providing a finished program for the primary care doctor. This approach has raised initiation of treatment from 25% to more than 55% following hip fractures.

Joseph Lane, MD, is professor of orthopaedic surgery at Weill Cornell Medical College and chief of the Metabolic Bone Disease Service at Hospital for Special Surgery in New York.
Disclosure: Lane has no relevant financial disclosures.

Multicomponent strategy necessary for fracture prevention

Compliance with fragility fracture prevention programs is challenging, and it has been well documented that rates of long-term adherence are low, particularly with oral medication. Research focusing on improving these low rates points toward a multifaceted approach. One important thing that can be done is to increase awareness, among both patients and physicians, of the importance of fragility fracture prevention. If treating physicians are not aware of osteoporosis management and treatment guidelines and know that it is something they need to think about, the prevention portion will never be initiated. This has been some of the motivation behind many of the American Academy of Orthopaedic Surgeons and American Orthopaedic Association initiatives like Own the Bone to try and encourage orthopedic surgeons to take the lead when it comes to fragility fracture prevention. I think that is number one — We cannot rely on the primary care physician alone to initiate prevention measures, and several studies show much higher rates of evaluation and treatment for osteoporosis when orthopedic surgeons take the lead.

The second thing that improves adherence is continued follow-up. Some studies have shown that if you bring the patients back for follow-up or you have the conversation more than once, then typically adherence is improved. From an orthopedic surgeon’s perspective, when patients come back for the follow-up visit, it is good practice to ask when the last bone mineral density test was done and whether the patient is taking calcium and vitamin D or other medications. In general, fracture prevention is greatly improved if physicians ensure that patients are aware of bone health and are following up appropriately. The same goes for fall prevention programs in terms of making sure patients follow up on suggested measures such as removing loose rugs or other fall risks in their homes. As a side note, EMTs in some areas are now being trained to check for these things when they are called to assist patients who suffered a fall at home.

Finally, making the medication regimens easier to follow also helps to improve long-term compliance. Extending the dosing intervals from daily or weekly to monthly or even annually helps. And, of course, improving on the side-effect profile of newer medications is key. The recent press related to side effects from bisphosphonate treatment has pushed many patients away from taking medication for their osteoporosis. It is important to consider the risk-benefit ratio whenever a patient is a candidate for antiresorptive medication.

Improving adherence is obviously a multilevel strategy, and many of these issues need to be addressed individually with each patient. In any case, I strongly believe that orthopedic surgeons have a responsibility to improve awareness of bone health issues among their patients.

Tamara Rozental, MD, is an associate professor in the department of orthopaedic surgery at Harvard Medical School and Beth Israel Deaconess Medical Center in Boston.
Disclosure: Rozental has no relevant financial disclosures.

Continued follow-up with patients is key

Knowing the individual patient and assessing some of the challenges that patient may face with osteoporosis medications may help with compliance. Writing down instructions about the medication as well as discussing these instructions with the patient may identify specific concerns the patient has about the regimen. The written instructions provide a reference for the patient that can be reviewed until the medication becomes a part of the patient’s regular routine. Having the patient repeat back to you about how he or she is going to take this new medication also helps to establish that the patient has understood your instructions. Involving family members in the discussion, especially for elderly patients or patients with memory loss, may be essential to ensure that the patient makes the osteoporosis medication a part of his or her standard regimen. Scheduling a follow-up visit or phone call and asking the patient about compliance is also important.

Physicians often do not know the cost of medications they are prescribing and patients may be embarrassed to discuss the issue with them. Being sensitive to costs and the availability of generic medications and considering alternative treatment regimens provides options patients that may give them the opportunity to find a choice that works for them financially.

Polypharmacy is a tremendous problem for many elderly patients, and remembering to take and refill all of their medications can be challenging. Choosing a regimen that is simple with a minimal dosing schedule and that is administered in a provider’s office or an infusion center may be helpful. These treatments are timed with a provider encounter, so if the encounter is missed, follow-up with the patient regarding the missed appointment occurs. Electronic medical records that trigger reminders about the missed appointments or the failure of patients to refill their medications can also provide opportunities to re-engage with the patient about the importance of the medication and compliance.

Susan V. Bukata, MD, is an associate professor and the division chief of orthopedic oncology at University of California, Los Angeles, Los Angeles.
Disclosures: Bukata is a consultant for Amgen, Merck and Eli Lilly and is on the speakers bureau for Eli Lilly.