[송무호의 비건뉴스] The inconvenient truth about osteoporosis⑧
In my last column, I said, “Prolia, currently the most commonly used injection for osteoporosis, reduces immunity and has the potential for hypocalcemia and jaw bone necrosis.” They also said that it is not a safe drug because there is a ‘rebound’ phenomenon in which bone density rapidly decreases when the drug is stopped.
In addition to these side effects of osteoporosis medication, atrial fibrillation, one of the cardiac arrhythmias, may also occur. [1,2,3]. Atrial fibrillation is a very serious problem as it causes stroke, a serious disease, and increases mortality. [4,5,6].
There is also a link with fatal esophageal cancer. There is also a report from Oxford University in the UK that the incidence of esophageal cancer doubled when taking oral osteoporosis medication for more than 5 years. [7]There is also an FDA report that esophageal cancer occurred after only 2-3 years of use, so caution is required. [8].
Evenity (romosozumab), a new injectable drug launched in 2018 for high-risk fracture groups, is administered by subcutaneous injection once a month for one year (in Korea, insurance coverage is recognized as a secondary treatment starting in 2021).
A protein called sclerostin secreted by osteocytes inhibits bone formation by osteoblasts and promotes bone resorption by osteoclasts to prevent excessive bone formation. Evenity It is a dual-mechanism treatment that artificially stops the production of this protein to promote bone formation and inhibit bone resorption. [9].
However, in the end, the result of increasing bone density by interfering with normal bone metabolism is similar to other osteoporosis drugs, so side effects occur similarly. Unlike bisphosphonates, Evenity does not have a long-lasting effect. Therefore, if treatment is discontinued, the effectiveness of the drug decreases rapidly, so other osteoporosis drugs such as Prolia must be continued after 12 injections.
In addition, the rate of death from cardiovascular diseases, including stroke, when injected for one year with Evenity was as high as 1.5% for Evenity, compared to 1.0% for Fosamax, raising concerns about cardiovascular side effects. [10]. Therefore, the FDA specified in the drug label, “Be sure to warn about the risk of myocardial infarction and stroke.”
A meta-study from Oxford University also said, “Be careful with drugs that artificially inhibit sclerostin, as they increase the risk of cardiovascular disease.” [11]. For this reason, the European Committee for Medicinal Products for Human Use (CHMP), which has a similar role to the U.S. FDA, banned the sale of this drug in Europe. [12].
There have been continued questions about why Evenity increases cardiovascular disease, but recently (April 2023), the decrease in blood levels of sclerostin, which inhibits bone formation, promotes calcification of arteries leading to the heart, causing myocardial damage. The mechanism that increases the frequency of infarction has been revealed [13].
In conclusion, Evenity, the latest drug, has the effect of increasing bone density in the short term, but it is not persistent, and considering the increase in cardiovascular side effects, it can hardly be considered a good drug. As such, osteoporosis drugs do not solve the fundamental cause, and new drugs cannot escape the constant controversy over side effects, so caution is required.
The bestseller ‘Prolia’ and the latest drug ‘Evenity’…
There is no medicine without side effects. Therefore, when people take medicine, they endure some side effects such as nausea, abdominal discomfort, and loss of appetite. However, how many people would choose to take this drug if they knew in advance that it could lead to jaw bone necrosis, atypical fractures, atrial fibrillation, and esophageal cancer?
Some readers will be very surprised and some may even be angry after reading this article. When choosing a drug, you must carefully weigh the pros and cons. None of the osteoporosis drugs currently available are safe. It is up to the patient to decide whether the benefits of taking the medication outweigh the harm. You may end up taking medication that doesn’t really help with the thought, “I’ll be fine,” and end up regretting it for the rest of your life.
All drugs described above are ‘drugs’. It is used in cases of severe illness or emergencies that follow it. However, osteoporosis, especially osteoporosis that occurs after menopause, is not a disease. Therefore, it is not a condition that fundamentally requires medication, and can be improved through lifestyle modifications such as exercise and diet.
Who ultimately protects one’s body?
Times are changing. Instead of being a passive consumer who blindly takes the medicine given by the hospital, we must become independent medical consumers who boldly refuse to take medicine when the disadvantages outweigh the advantages of the medicine. This is because it is you who protects your body, not the doctor.
Also, medical professionals should not be swayed by pharmaceutical companies’ hype and mechanically prescribe medicine, but should constantly question and reflect on Hippocrates’ “Do no harm” (editor’s note) spirit. We need to think about what is best for the patient.
I believe that very few medical professionals would use osteoporosis medication with such minimal effectiveness and serious side effects on their own family members. Medical care is truly precious. It is time to think about how to use it.
I would like to emphasize this once again. Taking medicine for osteoporosis is taking the wrong first step. Don’t rely on dangerous drugs. “Better safe than sorry”, safety comes first.
Song Moo-ho, MD, orthopedic specialist
references
1. DM Black, PD Delmas, R Eastell, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356:1809-1822.
2. SR Cummings, AV Schwartz, DM Black. Alendronate and atrial fibrillation. N Engl J Med 2007;356:1895-1896.
3. B Abrahamsen, P Eiken, K Brixen. 2009. Atrial fibrillation in fracture patients treated with oral bisphosphonates. Journal of Internal Medicine 2009;265(5):581-592.
4. PA Wolf, TR Dawber, HE Thomas, WB Kannel. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology 1978;28:973.
5. AS Go, EM Hylek, KA Phillips, et al. Prevalence of diagnosed atrial fibrillation in adults-national implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study. JAMA 2001;285:2370-2375.
6. M Zoni-Berisso, F Lercari, T Carazza, S Domenicucci. Epidemiology of atrial fibrillation: European perspective. Clin. Epidemiol 2014;6:213-220.
7. J Green, G Czanner, G Reeves, et al. Oral bisphosphonates and risk of cancer of oesophagus, stomach, and colorectum: case-control analysis within a UK primary care cohort. BMJ 2010;341:c4444.
8. D. K. Wysowski. Reports of esophageal cancer with oral bisphosphonate use. N Engl J Med 2009;360:89-90.
9. A Catalano, N Morabito, G Basile, et al. Zoledronic acid acutely increases sclerostin serum levels in women with postmenopausal osteoporosis. The Journal of Clinical Endocrinology & Metabolism 2013;98(5):1911-1915.
10. M.R. McClung. Romosozumab for the treatment of osteoporosis. Osteoporosis and Sarcopenia 2018;4(1):11-15.
11. J Bovijn, K Krebs, CY Chen, et al. Evaluating the cardiovascular safety of sclerostin inhibition using evidence from meta-analysis of clinical trials and human genetics. Science translational Medicine 2020;12(549):eaay6570.
12. Pharmaceutical business review https://www.pharmaceutical-business-review.com/news/chmp-evenity-negative-opinion/
13. J Zheng, E Wheeler, M Pietzner, et al. Lowering of circulating sclerostin may increase risk of atherosclerosis and its risk factors: evidence from a genome-wide association meta-analysis followed by Mendelian randomization. Arthritis & Rheumatology 2023; https://doi.org/10.1002/art.42538
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