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Treatment Options for Osteoporosis Patients

October 16, 2000|From Washington Post

Until recently, post-menopausal women seeking treatment for osteoporosis had few options other than estrogen replacement and calcium supplements.

Both are still widely used, but they've been augmented by several new and immensely profitable medications that retard bone loss and prevent fractures. Women who take any of these prescription drugs also must be sure to get at least 1,200 mg of calcium from food and supplements and at least 400 international units of vitamin D. They also are advised to engage in weight-bearing exercise (walking, running or weightlifting, not swimming or bicycling).

Most prescription medications for osteoporosis increase bone density by about 8%, and all reduce the chance of fractures. But important questions about the drugs remain unanswered. With the exception of estrogen, none of the medicines has been studied for longer than about four years, which means that their long-term safety and effectiveness are unknown.

Consumers contemplating drug therapy should keep in mind that the ads for these medicines typically make them sound more impressive than they actually are. That's because the ads usually highlight the relative risk or benefit. That percentage is much higher than the absolute, or actual, benefit or risk.

It's also important to remember that none of the medicines is a cure for osteoporosis. None builds new bone, the elusive goal of any future osteoporosis drug. One promising new medication, parathyroid hormone, is expected to be submitted for approval to the Food and Drug Administration later this year. It does generate bone growth, noted Dr. Robert Lindsay, founder of the National Osteoporosis Foundation.

Such measures as taking calcium, exercising and eliminating environmental hazards like throw rugs are equally important in preventing fractures, experts emphasize.

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Below is a primer on common osteoporosis drugs:

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* Estrogen: The most widely used drug for prevention. Available in various forms, sometimes with progesterone added to reduce the risk of endometrial cancer. Brand names include Premarin, Estrace, Prempro.

What It Does: Precise mechanism of action is unknown, but estrogen appears to slow the rate of bone loss by replacing the female sex hormone, levels of which decline at menopause.

Downside: Can increase the risk of breast cancer, cause blood clots, weight gain, headaches. Fracture prevention applies only to current users: Women who stopped taking estrogen had no difference in bone density or fractures than women who never took it, even if they took the drug for 10 years.

Effectiveness: Definitive results on hip-fracture reduction await the outcome of the Women's Health Initiative, a major federal study to be released in about 2007. Smaller studies have found that it reduces hip and wrist fractures by 60%, a number extrapolated from bone-density studies. The FDA has no figures for absolute risk reduction because the data are based on projections.

Approximate monthly cost: $24 to $29

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* Bisphosphonates Fosamax (alendronate); Actonel (risedronate)

What They Do: These new non-hormonal drugs target the skeleton (not other parts of the body, as does estrogen) by binding permanently to the surface of bone and slowing bone loss but not halting it. Approved for the prevention and treatment of osteoporosis, they are typically prescribed for women who have been diagnosed with osteoporosis, particularly those who have already broken a bone and are unable or unwilling to take estrogen.

Downside: Unwavering adherence to a strict regimen is required to prevent serious stomach problems and ensure absorption. Among other things, users must remain upright for at least 30 minutes after taking their morning pill. Gastrointestinal problems, some of them serious, have been reported.

Effectiveness: Fosamax: relative risk reduction for all fractures is 22%; absolute risk reduction, 3.3%. In a clinical trial, 12.9% of 1,545 women taking the drug broke a bone, compared with 16.2% of 1,521 women who took a placebo. Actonel: relative reduction in risk of vertebral fractures is 41%; absolute risk reduction 5%. In a clinical trial, 16.3% of 678 women who took a placebo had a vertebral fracture within three years, compared with 11.3% of 698 Actonel users.

Approximate Monthly Cost: Fosamax: $55 to $70; Actonel: $51 to $55

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* Selective Estrogen Receptor Modulators (SERMS) Evista (raloxifene)

What It Does: Approved for the prevention and treatment of osteoporosis in post-menopausal women, this drug mimics estrogen, possibly in the way it retards bone loss. But unlike estrogen, it does not increase cancer risk. Studies are underway to determine if it reduces breast-cancer risk.

Downside: Side effects include leg cramps, intensified hot flashes and increased risk of blood clots.

Effectiveness: Reduces relative risk of first vertebral fracture by 55%; 2.4% absolute risk reduction. In a clinical trial, 4.3% of 1,457 women who took placebo suffered vertebral fracture, compared with 1.9% of 1,401 who took the drug.

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