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Return To Osteoporosis Article Archive   Are There Alternatives to Bisphosphonates for Osteoporosis Prevention? By Doug Bremner Raloxifene (Evista) is a drug that acts at the estrogen receptor and is touted as having the beneficial effects of estrogen for osteoporosis, without the increased risk of uterine and ovarian cancer. However, Evista has other side effects similar to estrogen, including increased blood clotting (Ettinger et al 1999). Like the bisphosphonates, Evista does increase bone mineral density and reduce risk of vertebral fracture in postmenopausal women. However, each year it saves only about one or two women out of 100 from a vertebral fracture. It has not been shown to prevent nonvertebral fractures. In the Multiple Outcomes of Raloxifene Evaluation (MOR) study, 7705 postmenopausal women with osteoporosis received raloxifene or placebo in a randomized placebo controlled trial (Ettinger et al 1999). Although Raloxifene decreased vertebral fractures and increased bone density, it did not decrease non-vertebral fractures. Also only 22 women out of 7705 were saved from a hip fracture, which translates into one out of a thousand each year, a difference that wasn't statistically significant. And raloxifene has other side effects, like hot flashes, that result in a significantly greater number of women stopping its use because of side effects. As many as two out of 100 women stopped their medication because of hot flashes and other side effects, like depression, insomnia, rash, leg cramps, upset stomach, cough, and headaches. More concerning, one out of 100 women on Evista developed deep vein thrombosis, which can lead to pulmonary embolism, an event that kills one out of four people affected. Risk of deep vein thrombosis was increased three-fold. In other words, for every woman saved from a hip fracture, there are ten who have a life-threatening blood clot in their leg. In the Raloxifene Use for the Heart (RUTH) study, which was designed to assess the ability to prevent heart disease, 10,101 postmenopausal women with risk factors for heart disease were randomized to Raloxifene or placebo for five years of treatment. There was no reduction in heart disease events (533 versus 553). There was a reduction in breast cancer (40 versus 70) and vertebral fractures (64 versus 97) and an increase in stroke (59 versus 39) and blood clots in the leg (103 versus 71) (Barrett-Connor et al 2006). In other words, overall this drug causes as many diseases as it prevents. Based on this I don't recommend use of this medication. Another medication, calcitonin (Miacalcin, Calcimar), mimics a hormone secreted by the parafollicular cells of the thyroid. In the drug form it is derived from salmon. In the body it inhibits osteoclasts, promotes osteoblasts, and increases bone mineral density, which is why it was developed for treatment of osteoporosis. Miacalcin was approved by the FDA only on the basis of increasing bone mineral density, which went against their rules of only approving drugs for osteoporosis that reduced fractures. They promised to do more studies, but those studies didn't show benefit. The only dose that affected bone density was the high dose, and that had no effect on vertebral fracture, let alone hip fracture. I do not recommend use of this medication. Teriparatide (Forteo) is a form of parathyroid hormone, the hormone that regulates calcium and phosphate metabolism in the bone and kidney. It is given by daily injection and is approved for women with new vertebral fractures; it was approved with restrictions because it causes bone cancer in laboratory animals. At best it can reduce the risk from 0.7% to 0.2%. These differences were not statistically significant. By my calculations you it would cost two and a half million dollars to prevent a single hip fracture with this drug. Barrett-Connor E, Mosca L, Collins P, et al (2006): Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. New England Journal of Medicine 355:125-137. Ettinger B, Black DM, Mitlak BH, et al (1999): Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. Journal of the American Medical Association 282:637-645. Learn more about alternatives to medications and hidden risks of prescription medications in 'Before You Take That Pill: Why the Drug Industry May be Bad for Your Health: Risks and Side Effects You Won't Find on the Label of Commonly Prescribed Drugs, Vitamins and Supplements', by researcher and physician J. Douglas Bremner, MD. keywords: evista | osteoporosis | estrogen | raloxifene Bone Dexa

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