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| |  ECO MEETING: Fosamax Added To Ongoing HRT Increases Bone Mass BERLIN, GERMANY -- Sept. 14, 1998 -- Postmenopausal women with osteoporosis taking hormone replacement therapy (HRT) obtained greater increases in bone mass when Merck & Co., Inc.’s Fosamax(R) (alendronate) was added to their treatment, according to new research presented today at the European Congress on Osteoporosis. "Questions about the efficacy and safety of combined therapy with HRT and Fosamax are among the most frequent questions I hear from physicians and patients alike," said Robert Lindsay, M.D., chief of internal medicine and endocrinology, Helen Hayes Hospital, and president of the U.S. National Osteoporosis Foundation. "Until now, we've had to rely on mostly anecdotal experience about the combination of Fosamax and HRT to answer these questions." Fosamax is indicated for the treatment and prevention of osteoporosis in postmenopausal women. The current labelling in the United States for Fosamax states that the safety and effectiveness of concurrent use of HRT and Fosamax in postmenopausal women has not been established. "In the United States alone we estimate that about five million postmenopausal women on HRT continue to have low bone mass and therefore remain at increased risk for fracture which may result in pain, loss of height, decreased mobility, hospitalisation and even death. The magnitude of the problem is vastly greater on a world-wide basis," Lindsay said. "The results of this study clearly show that for postmenopausal women with low bone mass, the addition of Fosamax to HRT therapy may provide a bone-building advantage for this at-risk population – and, very importantly, the combination is generally well-tolerated." The study showed that women who received the combination of Fosamax and HRT achieved increases in bone mass at the spine and trochanter (part of the hip) that were two to three percent greater than those observed in women on HRT alone at 12 months. Women on combination therapy also gained more bone mass at the portion of the hip known as the femoral neck, but the difference was not statistically significant. The increases in bone mass, relative to baseline, were: The study included 428 postmenopausal women at 38 U.S. sites who were randomised to receive the combination of Fosamax and HRT (214 patients) or HRT alone (214 patients) along with recommended levels of calcium and Vitamin D. Women in the study were already being treated with HRT for at least one year prior to the start of the study (average duration of therapy 9.5 years), were postmenopausal for at least five years and had low bone mass levels greater than or equal to two standard deviations below normal adult peak bone mass at the spine or hip. All women in the study continued treatment with their usual regimen of HRT for the duration of the one-year study (estrogen: conjugated estrogens, or oral/transdermal estradiol equivalent to at least 0.625 mg/day Premarin; progestin: cyclic or low dose continuous medroxyprogestone acetate). There were no significant differences in average age (62 years average), time since menopause (15 years average), or duration of HRT (9.5 years average) between the two groups. The combination of Fosamax and HRT was generally well tolerated in the study. The rate of adverse experiences (AE) considered by the investigator to be drug-related was similar for women given the combination and those receiving HRT alone. The rate of upper gastrointestinal AE considered to be drug-related was the same for both study groups. These findings are consistent with other clinical studies where AE associated with Fosamax usually were mild and generally did not require discontinuation of therapy. Fosamax has been studied in more than 17,000 women in clinical trials and used by more than three million women world-wide. Abdominal pain was the most frequently reported AE in clinical trials and has been reported slightly more frequently in patients taking Fosamax relative to those taking placebo. Digestive disturbances such as nausea, heartburn (acid regurgitation) and stomach irritation (gastritis) occurred with less frequency and were similar in the groups receiving either Fosamax or placebo. Fosamax, like some other drugs, should be used with caution in women with active upper GI disease. Patients with certain disorders of the esophagus, inability to stand or sit upright for 30 minutes, low levels of calcium in their blood, severe kidney disease, and who are pregnant or nursing should not take Fosamax. In marketed use, esophageal AE such as esophagitis (inflammation of the esophagus), esophageal ulcers and erosions, occasionally with bleeding, have been reported in patients receiving treatment with Fosamax. The risk of severe esophageal AE appears to be greater in patients who fail to follow dosing instructions. Related Links: Fosamax, Merck & Co., Inc.
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