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| |  Fosamax (Alendronate) Shows Continued Benefits After Seven Years TAMPERE, FINLAND -- May 10, 2000 -- The latest results from a study on Fosamax(R) (alendronate sodium), Merck & Co., Inc.'s osteoporosis medicine, showed that after seven years of continuous use the drug continued to build bone in the spine, maintained bone at the hip, and was generally well-tolerated in the trial. The results presented at the 27th European Symposium on Calcified Tissue were derived from the largest, randomized, long-term study of an osteoporosis therapy. Merck plans on continuing the study for another three years to examine the efficacy and safety of Fosamax for a total of 10 years. "With the availability of alternative osteoporosis treatment options in recent years, many physicians and patients have expressed interest in learning more about the long-term effects of these therapies," said investigator Richard Tonino, M.D., associate professor of medicine, University of Vermont College of Medicine. "Now patients and physicians can feel reassured that continued use of Fosamax provides continued bone benefits while maintaining a good safety and tolerability profile." Results of the study also showed that when treatment with Fosamax stopped after five years, bone density at the spine and hip remained generally stable for an additional two years and did not result in accelerated bone loss. Fosamax is administered once daily for the prevention (5 mg) and treatment (10 mg) of postmenopausal osteoporosis. In the treatment of osteoporosis, the drug is the only therapy approved by the Food and Drug Administration (FDA) to increase bone mineral density and reduce the incidence of spine fractures and the incidence of potentially devastating fractures of the hip. The drug also is indicated for the treatment of Paget's disease and the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. The seven-year data are from the second extension of the original Phase III clinical trials. Two randomized, placebo-controlled Phase III clinical trials of three years duration continued into two sequential double-blind extensions, each of two-years duration (seven years total). The second extension into years six and seven was open to all women with osteoporosis from the Phase III trial who had received five years of continuous treatment with Fosamax. More than half (59 percent) of the women (n=350) originally randomized to Fosamax in the initial Phase III studies participated in the second extension study. The mean age at their initial start of treatment was 63 years and on average the women were 16 years postmenopausal. Women who were originally randomized to either Fosamax 5 mg once daily or Fosamax 10 mg once daily continued on those therapies into years six and seven (n=113, n=122, respectively). Women who originally received Fosamax 20 mg once daily for two years followed by Fosamax 5 mg once daily for three years were switched to placebo (n=115) for years six and seven. All treatment groups received 500 mg of calcium daily. The primary endpoint of the study was change in lumbar spine bone mineral density. Secondary endpoints included changes in bone mineral density at the hip, forearm and total body and changes in biochemical markers of bone turnover. Safety and tolerability were evaluated for all treatment groups during the two-year extension. The study design and trial results were presented by Dr. John Yates, executive director, Endocrine and Metabolism Clinical Research, Merck Research Laboratories. Results from the study showed that after seven years of treatment with Fosamax, bone mineral density at the lumbar spine, hip trochanter and femoral neck increased, relative to baseline at month zero, by the following totals: --At the lumbar spine, 11.4 percent for the Fosamax 10 mg once daily group and 8.2 percent for the Fosamax 5 mg once daily group; During years six and seven, bone mineral density at the lumbar spine significantly increased by about 1.5 percent relative to year five while bone mineral density at the hip was maintained (from year three) and total body and forearm bone mineral density was maintained (from year five). Decreases in biochemical marker levels of bone turnover also remained stable during years six and seven. Among women previously taking Fosamax who were switched to placebo, there was no significant decline in bone mineral density at the spine or hip during the two-year extension, although there were small, nonsignificant declines at the hip. Small but significant decreases in bone mineral density at the forearm (0.8 percent) and total body (0.5 percent) were observed. Moderate increases in biochemical markers of bone turnover when treatment was discontinued were observed, however, mean bone resorption remained well below baseline levels (58 percent decrease for urinary N-telopeptides of type 1 collagen) and within the normal range for premenopausal women. Fosamax was well tolerated in the study. The incidence of upper gastrointestinal (GI) adverse events, both overall and those considered to be drug-related, was similar among the three treatment groups in the two-year extension. These findings are consistent with the three-year and five-year treatment studies and with other clinical studies with Fosamax in which the overall GI tolerability profile of Fosamax was found to be similar to placebo. Like other drugs in the same class, known as bisphosphonates, Fosamax should be used with caution in people with certain stomach or digestive problems. Fosamax should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, Fosamax should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to Fosamax or in patients who are pregnant or nursing. Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in those patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and consult their doctor. Fosamax is a nonhormonal, bone-specific therapy that has been studied in more than 17,000 patients in randomized clinical trials to advance the understanding of the prevention and treatment of osteoporosis. Fosamax was approved in the United States by the FDA in 1995 for the treatment of postmenopausal osteoporosis (10 mg once daily) and for treatment of Paget's disease of bone (40 mg once daily). In 1997, Fosamax (5 mg once daily) was approved for the prevention of osteoporosis in postmenopausal women at risk of osteoporosis and Fosamax (10 mg once daily) was approved for the prevention of fractures in postmenopausal women who have osteoporosis. In June 1999, Fosamax was approved as the first medication for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids (commonly referred to as corticosteroids or steroids) in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through its joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care. Related Links: Fosamax (alendronate sodium) and Merck & Co., Inc.
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