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| |  Fosamax is First Nonhormonal Therapy to Prevent Bone Loss SEATTLE, Sept. 12, 1996 -- A new study confirms that Fosamax(R) (alendronate sodium), a nonhormonal medicine that has been shown to prevent fractures in postmenopausal women with osteoporosis, can prevent the bone loss that leads to the disease itself. Researchers presented two-year results of the Early Postmenopausal Intervention Cohort (EPIC) Study, a six-year study to evaluate the efficacy and safety of Fosamax in preventing bone loss in postmenopausal women. The results were presented at the annual meeting of the American Society for Bone and Mineral Research today. Data from EPIC show that Fosamax (5 mg per day) stops bone loss and restores bone mass at the spine and hip -- two common sites for osteoporotic fracture. The results show that Fosamax is a promising, nonhormonal alternative to hormone replacement therapy for preventing osteoporosis and had a tolerability profile similar to that of placebo. "The study shows that in postmenopausal women taking Fosamax to prevent osteoporosis, the drug reverses the process of bone loss -- a process that normally accelerates as women's estrogen levels decline," according to researcher Michael McClung, M.D., director of the Oregon Osteoporosis Center, Providence Health System in Portland, Ore., and a U.S. investigator for EPIC. "In the women who took the drug over the two years of the study, Fosamax turns back the clock," he said. Based on the amount of bone lost by women in the placebo group, and the amount of bone mass gained by women on Fosamax, EPIC researchers estimate that women in the group treated with Fosamax had their bone mass restored to levels they had two to four years before the start of the study. The finding that Fosamax can prevent bone loss that leads to osteoporosis is based on two-year results from the randomized, double-blind, placebo-controlled, six-year EPIC study, being conducted at four sites, including two in the United States. The 1,609 postmenopausal women, ages 45 to 59 in the study, were treated with either Fosamax 2.5 or 5 mg per day (997 women), hormone replacement therapy (HRT) (110 women) or placebo (502 women). The group taking Fosamax included women who refused or could not take HRT. Women in the U.S. HRT group took conjugated equine estrogens and medroxyprogesterone acetate -- the combination of estrogen/progestin most commonly used in the U.S. -- while women in European HRT groups took a formulation of estrogen not available in the United States. The goal of a prevention therapy for osteoporosis is to prevent bone loss. In this study, both Fosamax and HRT prevented bone loss and restored bone mass. "While it was already well known that HRT can prevent bone loss, this study confirms that a nonhormonal therapy, Fosamax, can achieve these same results. The differences between Fosamax and the formulation of estrogen used in the United States in increasing bone mass were not statistically significant at the spine, hip or total body," said McClung. Adverse events (any health problem occurring during the study) that were considered by the investigator to be possibly drug related occurred in 11.2 percent of the placebo group and 11.6 percent of the group treated with Fosamax. Of women who received hormone replacement therapy, 87.3 percent experienced an adverse event that was considered to be possibly related to treatment with HRT. These adverse events were typical of adverse events experienced by women who take HRT. Adverse events resulted in discontinuation of the study in 2.2 percent of women on placebo, 2.0 percent of women on v and 11.8 percent of women on HRT. In the study, women who took Fosamax (5 mg) experienced increases in BMD of the spine and hip of 3.46 percent and 1.85 percent, respectively, compared to their BMD at the start of the study. Women in the U.S. HRT group had increases of 4.04 percent and 1.83 percent, while women in the European HRT group had increases of 5.14 percent and 3.21 percent. Women in the placebo group experienced a loss in bone mass of -1.78 percent at the spine and -1.42 percent at the hip after two years. Many women in the study took calcium supplements. Based on these results from EPIC, and other data showing safety and efficacy of Fosamax in preventing bone loss presented at ASBMR in 1995, Merck & Co., Inc. submitted a supplemental New Drug Application to the U.S. Food & Drug Administration for Fosamax for the prevention of osteoporosis on April 29, 1996. The EPIC study will continue through June 1999 to confirm the effect of Fosamax in preventing osteoporosis over a longer term. "By preventing bone loss, women can avoid osteoporosis and the debilitating fractures it can cause," said McClung. "These data are very significant for postmenopausal women who want to keep their bones strong but may be trying to do so with calcium and exercise alone, which are not sufficient to prevent bone loss." Osteoporosis affects more than 25 million Americans -- 80 percent of them women. Because osteoporosis has no visible signs until fractures have occurred, many do not know they are affected until they have a fracture. Women begin to lose bone during their 30s and 40s, but this process greatly accelerates after menopause when estrogen levels drop. Menopause is the single most important risk factor for osteoporosis in women. More than two-thirds of women under age 65 have lower than normal bone mass. Fosamax was cleared for marketing on Sept. 29, 1995, for the treatment of osteoporosis in postmenopausal women (10 mg once daily) and for the treatment of Paget's Disease of bone, a chronic bone disorder (40 mg once daily). Patients must take Fosamax at least one-half hour before the first food, beverage or medication of the day with a full glass of plain water (six to eight ounces) only. After swallowing Fosamax, patients must not lie down and should stay fully upright (sitting or standing) for at least 30 minutes and until after first food of the day. In clinical studies, the most commonly reported drug-related side effects in patients taking Fosamax for treatment of postmenopausal osteoporosis were abdominal and musculoskeletal pain. Less frequently reported were other digestive disturbances such as nausea, heartburn and irritation or ulcer of the esophagus. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health. Fosamax is the Merck registered trademark for alendronate sodium.
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