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22 Executive Briefing Sponsored by Cutting Mortality Risk by Shining Light on Osteoporosis & Vertebral Compression Fracture Treatment By Megan Wood T he most common osteoporotic fracture, vertebral compressions (VCF) reflect bone fragility and will often push a pa- tient down a path of increased morbidity. VCF symptoms can include impaired gait, disability, reduced lung function, early satiety, future frac- ture risk and mortality. The National Osteoporosis Foundation esti- mates that 10 million Americans have osteopo- rosis, with an osteoporotic fracture occurring every three seconds and a vertebral fracture oc- curring every 22 seconds globally. 1 As a result of the population advancing in age and changing diet, the fracture rate isn›t diminishing — U.S. osteoporotic-caused fractures will likely reach 3 million by 2025, up from 2 million in 2005. 2 Patients who have a VCF face a five-fold in- creased risk of suffering a subsequent vertebral fracture when compared with their pre-mor- bid condition or age matched controls. 3, 4 As the number of prevalent vertebral fractures increases, so does the risk for additional fractures as well as the mortality rate. 5 Medtronic is doing its part to raise awareness about the severity of osteoporosis and resultant VCFs by forming a unique collaboration with the National Osteoporosis Foundation (NOF) and clinicians, increasing awareness about treatment options that are presently available. "[Medtronic has] alerted the nation as a whole to the major public health threat [of osteoporosis]. We are able to educate the public on ways to prevent, diagnose and treat osteoporotic patients with VCFs," says Medtronic General Manager Jeff Cambra. "As clinicians face an increasing number of VCF cases, they should consider the benefits of vertebroplasty and kyphoplasty to reduce patient pain and improve quality of life." Threat of undiagnosed osteoporosis and VCFs The number of people suffering osteoporotic fractures nationwide is increasing, especially among older women. The January 2015 issue of Mayo Clinic Proceedings featured an article com- paring hospitalizations for various conditions to hospitalizations for osteoporotic fractures in women 55 years and older. The 12-year study revealed 4.9 million hospitalizations for osteopo- rotic fractures in women, more than myocardial infarction, stroke or breast cancer. 6 The popula- tion facility-related hospital costs for osteopo- rotic fractures totaled $5.1 billion, far more than the $4.3 billion for myocardial infarction and $3 billion for stroke in the same patient population. "Many experts now realize that there is a crisis caused by the declining rate of testing, diagnosis and treatment of high-risk patients," says Andrea Singer, MD, National Osteoporosis Foundation Clinical Director. "If these patients go untested and untreated, the consequences may include debilitating fractures that cause disability, loss of independence and even death." Osteoporotic fractures account for a significant economic burden on the healthcare system, but identifying high-risk patients early can lead to better care and lower treatment costs. Currently two-thirds of VCFs are initially asymp- tomatic and under-diagnosed; this provides op- portunity for clinicians to proactively drive educa- tion on the risks associated with osteoporosis and spine fractures as well as the associated econom- ic impact on the healthcare environment. "The finding of a previously unrecognized vertebral fracture may change the diagnostic classification and thus necessitate a more ag- gressive approach to treatment than warranted based on bone mineral density measurement alone," explains Dr. Singer. By taking osteoporotic medications after suf- fering a VCF, patients greatly decrease their risk of subsequent fractures, but many patients choose to avoid medication because of conflict- ing information they hear. A misunderstood condition Many clinicians are under the impression VCFs are untreatable and thus dubbed them "benign fractures," but this is a mistake. "We had [in the 1980s], a conceptual framework that was based on how younger people heal ver- tebral compression fractures. In reality, the elderly often take longer to improve their pain and can decline during the period of conservative thera- py," says Joshua A. Hirsch, MD, Boston-based Mas- sachusetts General Hospital's NeuroInterventional Radiology director and the American Society of Spine Radiology's immediate past president. In the 1980s, French practitioners developed a technique to percutaneously inject cement into the bone. While the incident case was a benign tumor of the cervical spine, these physicians soon realized the same technique could be used to sta- bilize fractures and rapidly reduce the associated pain. Interventional radiologists and surgeons in the United States later saw this procedure and mir- rored it with vertebroplasty. Researchers then de- veloped a cousin procedure — kyphoplasty, which involves mechanically treating the fracture by in- serting and inflating a balloon to create an open cavity inside the bone for injecting bone cement designed to stabilize the spine. When Dr. Hirsch began performing these aug- mentation procedures in the 1990s, many cli- nicians were not familiar with the severity of osteoporosis. Now, there is a greater apprecia- tion for osteoporosis as a medical problem and vertebroplasty or kyphoplasty as a solution for quicker pain relief. "These communities of elderly patients now are vibrant and interconnected. Patients, relatives and friends began telling each other of these therapies," he says. A variety of treatment methods now exist for VCFs, but biases and misinformation still circulate. Some of this misinformation stems from two studies published in The New England Journal of Medicine in 2009. These investigations compared vertebroplasty to another treatment described as placebo, and found no significant differences in pain relief. The mainstream news picked up the studies and voiced that vertebroplasty offers no more benefit than a sham procedure. Dr. Hirsch argues the studies did not consider many other factors, such as height restoration or even the nature of the placebo. He laments that "opportunities for scientific discourse that might have enhanced the approach to these challeng- ing patients were lost in the at times acrimoni- ous discussion that ensued." The smaller of the two NEJM studies were con- ducted in Australia, and the country pulled public funds from vertebroplasty as a result. In response, researchers conducted the VAPOUR (vertebroplasty for acute painful osteoporotic fractures) trial and presented data at the Amer- ican Society of Spine Radiology meeting in San Diego, held from Feb. 23 to Feb. 26, 2017. VAPOUR constituted a masked trial like the prior NEJM trials of 2009, which offers a higher level of evidence compared to open label trials. Unlike those two prior trials on the subject, researchers enrolled 120 patients with the most painful frac- tures who reported a pain duration of less than six weeks. Additionally, the trial included both in- patients and outpatients, which differed from pre- vious masked trials that only targeted outpatients. The trial involved four centers in Sydney, Aus- tralia, as well as an independent data collection agency and independent statisticians. Research- ers randomly assigned patients to either under- go vertebroplasty or placebo intervention. A main benefit of this study was that patients were unable to access vertebroplasty in any of the four centers outside of participating in the trial. The Lancet-published study supported vertebro- plasty's treatment benefits over the sham proce- dure. 7 Forty-four percent of the vertebroplasty pa- tients achieved the primary outcome, compared to only 21 percent of the control group. Limitations of this study included the single center predomi- nance; the high volumes of cement injected; and the reality that many patients endure pain for lon- ger than six weeks. "I never have said we should ig- nore the New England trial; tri- als are about refining our expe-