The most common osteoporotic fracture, vertebral compressions (VCF) reflect bone fragility and will often push a patient down a path of increased morbidity. VCF symptoms can include impaired gait, disability, reduced lung function, early satiety, future fracture risk and mortality.
The National Osteoporosis Foundation estimates that 10 million Americans have osteoporosis, with an osteoporotic fracture occurring every three seconds and a vertebral fracture occurring 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 increased risk of suffering a subsequent vertebral fracture when compared with their pre-morbid 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 comparing 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 osteoporotic fractures in women, more than myocardial infarction, stroke or breast cancer.6 The population facility-related hospital costs for osteoporotic 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 asymptomatic and under-diagnosed; this provides opportunity for clinicians to proactively drive education on the risks associated with osteoporosis and spine fractures as well as the associated economic impact on the healthcare environment.
"The finding of a previously unrecognized vertebral fracture may change the diagnostic classification and thus necessitate a more aggressive approach to treatment than warranted based on bone mineral density measurement alone," explains Dr. Singer.
By taking osteoporotic medications after suffering a VCF, patients greatly decrease their risk of subsequent fractures, but many patients choose to avoid medication because of conflicting 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 vertebral compression fractures. In reality, the elderly often take longer to improve their pain and can decline during the period of conservative therapy," says Joshua A. Hirsch, MD, Boston-based Massachusetts 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 stabilize fractures and rapidly reduce the associated pain. Interventional radiologists and surgeons in the United States later saw this procedure and mirrored it with vertebroplasty. Researchers then developed a cousin procedure — kyphoplasty, which involves mechanically treating the fracture by inserting 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 augmentation procedures in the 1990s, many clinicians were not familiar with the severity of osteoporosis. Now, there is a greater appreciation 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 challenging patients were lost in the at times acrimonious discussion that ensued."
The smaller of the two NEJM studies were conducted 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 American Society of Spine Radiology meeting in San Diego, held from Feb. 23 to 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 fractures who reported a pain duration of less than six weeks. Additionally, the trial included both inpatients and outpatients, which differed from previous masked trials that only targeted outpatients.
The trial involved four centers in Sydney, Australia, as well as an independent data collection agency and independent statisticians. Researchers randomly assigned patients to either undergo 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 vertebroplasty's treatment benefits over the sham procedure.7 Forty-four percent of the vertebroplasty patients achieved the primary outcome, compared to only 21 percent of the control group. Limitations of this study included the single center predominance; the high volumes of cement injected; and the reality that many patients endure pain for longer than six weeks.
"I never have said we should ignore the New England trial; trials are about refining our experience, understanding what we can do well, what we can do better and defining the population," Dr. Hirsch explains. "This VAPOUR trial demonstrates the dangers of forming such strong opinions in vulnerable populations based on a total of about 200 patients, 100 of which went into therapy."
Limitations of this study included the single center predominance; the high volumes of cement injected; and the reality that many patients endure pain for longer than six weeks. Dr. Hirsch, who wrote the invited comment, noted that conservative therapy was not risk free; further height loss in the sham group led to meaningful complications.8
Clinical evidence
A heated debate about whether augmentation offers a mortality benefit has captured the industry for years, resulting in a variety of trials.
Several recent large clinical studies followed patients for at least 12 months after VCF. Four studies revealed balloon kyphoplasty and vertebroplasty offered patients lower mortality risk compared to those patients receiving non-surgical management.
1. Published in Journal of Bone and Mineral Research in 2011, the Edidin A. et al., study utilized Medicare data from 2005 to 2008 to assess the mortality risk for VCF patients receiving non-operated management, balloon kyphoplasty or vertebroplasty. Of the 858,978 patients newly diagnosed with VCFs, 13.9 percent received balloon kyphoplasty and 7.4 percent received vertebroplasty. Researchers found adjusted survival rates of 57.3 percent for vertebroplasty patients; 62.8 percent for kyphoplasty patients; and 50 percent for non-operated patients.9
2. Baltimore-based Johns Hopkins researchers compared vertebroplasty, kyphoplasty and non-operated management for VCF patients in the Chen et al., a 2013 study published in The Journal of Bone & Joint Surgery. The study, involving 72,693 VCF patients, demonstrated kyphoplasty yielded longer patient survival compared to vertebroplasty and non-operated treatment.10
3. The 2014 Lange et al., study published in Spine, involved 3,607 patients with osteoporotic vertebral compression fractures. Of those patients, 598 underwent operations. Over the five-year period, the operated group was 43 percent less likely to die compared to the non-operated cohort. Further, those patients receiving balloon kyphoplasty had a 66.7 percent 60-month adjusted survival rate compared to the 58.7 percent survival rate for those receiving vertebroplasty.11
4. The 2015 Edidin A. et al., Spine-published study encompassed 141,343 balloon kyphoplasty patients and 75,364 vertebroplasty patients. Researchers found a 55 percent higher adjusted mortality risk for the non-operated patients than the balloon kyphoplasty patients and a 25 percent higher mortality risk than the vertebroplasty patients.12
"The mortality benefit always made intuitive sense when one compares the fundamental tenets of conservative therapy which include limitation of activities, back brace and narcotic medication to early mobilization," says Dr. Hirsch of the study. "While claims-based data should always be interpreted with caution, Chen's analysis raises important questions for patients who may have been denied the opportunity to consult with a specialist regarding the role augmentation might offer in their case. Put differently, what the medical community lacked, I felt, was a dialogue that would have allowed for a data-driven determination on a person-by-person level."
One study, however, discovered no significant differences in mortality risk between augmented patients and non-surgical management patients. The 2013 McCullough B. et al., published in JAMA Internal Medicine, involved 15,851 control patients and 10,541 augmented patients. The study utilized a 20 percent sample of Medicare data.13
Medtronic has been active in the augmentation scene for decades, with surgeons first performing its Kyphon® Balloon Kyphoplasty in 1998. Surgeons have leveraged Medtronic's balloon kyphoplasty to treat more than 1 million fractures; more than 15,000 physicians have undergone balloon kyphoplasty training worldwide.
"Balloon kyphoplasty is one of the few treatment solutions in clinical studies to give patients pain relief and quality of life," Mr. Cambra says.
To prove the technique's effectiveness, the 21-center Fracture Reduction Evaluation study compared Medtronic's Kyphon® Balloon Kyphoplasty with non-surgical treatment for acute VCF. Researchers found balloon kyphoplasty relieved back pain, enhanced patient satisfaction and improved mobility and quality of life to a greater effect than non-surgical care.
"Medtronic continues to invest in clinical and outcomes research for our balloon kyphoplasty, to offer evidence of health benefits and treatments of VCF," Mr. Cambra adds. The company is currently collecting balloon kyphoplasty 12-month outcome data as well as daily living quality of life and safety measures.
Stopping the crisis
Every May, NOF raises awareness about prevention, diagnosis and treatment during National Osteoporosis Month.
The foundation strongly supports the American Society of Bone and Mineral Research Call to Action to enhance screening, diagnosis and treatment of high-risk individuals. Further, the bone health industry is striving to prevent fractures as well as work with patients on informed decision-making for osteoporosis treatments.
In February 2017, NOF collaborated with more than 300 patient advocacy and health organizations to draft a letter to Congress concerning non-interference in Medicare Part D negotiations, urging patient access to all osteoporosis treatment medications.
Medtronic is actively contributing to the NOF's cause, offering a continuing education opportunity highlighting cases and mortality data for clinicians to apply in their practices. Medtronic reaches more than 20,000 clinicians through its digital marketing campaign, enlightening them about the risks of leaving VCFs untreated.
Through its collaboration with NOF, Medtronic contributes to the foundation's series of educational materials, such as Bone Basics. Medtronic is currently bundling the series into a digital and print publication for clinicians to share with patients, touching on topics such as VCF risk factors, moving safely and spine fractures.
Healthcare providers may also access NOF's professional learning center as well as attend its annual clinical conference for more information about osteoporosis and fractures.
Medtronic also sponsors or supports a variety of educational and awareness efforts:
• Referral education activities
• Dedicated interventional sales reps
• Peer-to-peer educational balloon training programs
• Clinical update symposiums
• Patient education
• Direct mailers
• Assistance to local education programs
• Community outreach
References
1Johnell O and Kanis JA (2006) Osteoporosis Int 17: 1726
2Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A Tosteson A. Incidence and Economic Burden of Osteoporosis-Related Fractures in the United States, 2005-2025. J Bone Miner Res 2007. 22(3): 465-475.
3Lindsay R, et al., Risk of new vertebral fracture in the year following a fracture. JAMA. 2001; 285(3):320-33
4Ross P, et al., Pre-Existing Fractures and Bone Mass Predict Vertebral Fracture Incidence in Women. Ann Intern Med. 1991; 114(11):919-923.
5Kado DM, et al. (1999) Arch Intern Med 159:1215
6Singer A, et al. Mayo Clin Proc. 2015; 90: 53-62
7Clark W, et al., Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet.
8(1).pdf
9Edidin AA, Ong KL, Lau E, Kurtz SM. Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. J Bone Miner Res. 2011 Jul;26(7):1617-26. doi: 10.1002/jbmr.353.
10Chen A, et. al, Impact of Nonoperative Treatment, Vertebroplasty, and Kyphoplasty on Survival and Morbidity After Vertebral Compression Fracture in the Medicare Population. J Bone & Joint Surgery, 2013.
11Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine (Phila Pa 1976). 2014 Feb 15;39(4): 318-26. doi: 10.1097/BRS.0000000000000135. PubMed PMID: 24299715.
12Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality after Vertebral Fractures: Comparison of Vertebral Augmentation and Non-Operative Management in the Medicare Population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228-41. doi: 10.1097. PubMed PMID: 26020845.
13McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013 Sep 9;173(16):1514-21. doi: 10.1001/jamainternmed.2013.8725. PubMed PMID: 23836009; PubMed Central PMCID: PMC4023124.
BKP is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. Keep in mind that results of this procedure may vary, and all treatment and outcome results are specific to the individual patient. Results may vary. A prescription is required. The complication rate for balloon kyphoplasty has been demonstrated to be low.
There are risks associated with the procedure, including serious complications, and though rare, some of which may be fatal. These include, but are not limited to heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood, fat or cement that migrates to the lungs, heart, or brain). Other complications include infection and leakage of bone cement into the muscle and tissue. Cement leakage into the blood vessels may result in damage to the blood vessels, lungs, heart, and/or brain. Cement leakage into the area surrounding the spinal cord may result in nerve injury that can, in rare instances, cause paralysis.
Please consult your physician for a complete list of indications, contraindications, benefits, and risks. Only you and your physician can determine whether this procedure is right for you.
Learn more about osteoporosis, visit www.nof.org.
Learn more about spine fracture at www.spine-facts.com.
Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, MD.
This article is sponsored by Medtronic.
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