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| |  ESCT: Fosamax Prevents Rapid Bone Loss In Women Who Discontinue HRT MAASTRICHT, THE NETHERLANDS -- May 10, 1999 -- Results of a new study have shown for the first time that Merck & Co., Inc.’s Fosamax(R) (alendronate sodium) not only stopped the bone loss that occurs when hormone replacement therapy (HRT) is discontinued, but also significantly increased bone mineral density (BMD) at the hip and spine, two of the most common sites of osteoporotic fracture. Previous research had already demonstrated that Fosamax prevents the bone loss associated with menopause. Fosamax is indicated for the prevention and treatment of osteoporosis in postmenopausal women and for the treatment of Paget's disease of the bone. There are two times in a woman's life when she may be more likely to experience rapid bone loss: in the three to five years following cessation of menses when there is a decline in her own hormones associated with menopause; or if she is using HRT for treatment of menopausal symptoms, bone loss is likely to be accelerated when she discontinues this therapy. "Although HRT has been shown to slow the rate of bone loss in women following menopause, this effect is often lost when women stop taking HRT," said Nuria Guanabens, M.D., Hospital Clinico, Barcelona, Spain, who presented the new study at the European Symposium on Calcified Tissues. "The data presented are important because they showed that when postmenopausal women discontinued HRT, they not only lost the benefit of HRT, but they also experienced a high rate of bone loss, particularly at the spine. The bone loss in these women was similar to the rapid loss seen following menopause in women who did not take HRT or other bone-building therapies. "Furthermore, in the study the data demonstrated that Fosamax effectively prevented bone loss in postmenopausal women who stopped taking HRT." The one-year multi-centre study in nine countries included 144 women who were at least three years post-menopause and who had discontinued HRT within three months of entry into the trial. Women in the study had baseline BMD levels between 1.5 and 3.5 standard deviations below normal adult peak bone mass, but did not have a history or evidence of osteoporotic fracture. The World Health Organization defines osteoporosis as BMD of less than 2.5 standard deviations below peak adult bone mass. Women in the study were randomised to placebo or Fosamax 10 mg once-daily. There were no significant differences in baseline characteristics between groups including age (average 57.3 years, range 39 years to 74 years), weight, height, average time since menopause (11.5 years, range 1.5 years to 45.3 years) and baseline BMD. All patients in the study also received 500 mg calcium once-daily. At the end of the one-year study, women who received placebo generally lost bone at the spine and hip relative to their baseline values. In contrast, women treated with Fosamax increased BMD at both the spine and hip compared to placebo, and increased or preserved BMD relative to baseline. The changes in BMD with Fosamax at month 12 relative to placebo were as follows: -- At the lumbar spine, there was a 5.48 percent difference between the two groups: a 2.33 percent increase from baseline for those taking Fosamax versus a 3.18 percent decrease for those on placebo. Of patients on placebo, 41.5 percent lost more than 5.0 percent of their lumbar spine BMD compared to none of the patients in the group taking Fosamax. -- At the hip femoral neck, there was a 1.61 percent difference between groups: a 0.22 percent increase from baseline for those taking Fosamax versus a 1.37 percent decrease for those on placebo; -- At the hip trochanter, there was a 2.30 percent difference between groups: a 2.51 percent increase from baseline for those taking Fosamax versus a 0.23 percent increase for those on placebo; -- For the total hip, there was a 1.86 percent difference between groups: a 1.68 percent increase from baseline for those taking Fosamax versus a 0.11 percent decrease for those on placebo; and -- For the total body, there was a 1.78 percent difference between groups: a 0.99 percent increase from baseline for those taking Fosamax versus a 0.74 percent decrease for those on placebo. "The results demonstrated that women in this study experience rapid bone loss when they stopped HRT treatment after menopause," Dr. Guanabens said. "These results suggest that the use of Fosamax may provide a bone-building benefit for this at-risk population." In the study, Fosamax was generally well tolerated with a similar incidence of adverse experience (AE) reports considered to be drug-related for women who received Fosamax and women who received placebo. The rate of upper gastrointestinal AEs was also similar between the two groups. These findings are consistent with other clinical studies with Fosamax. A nonhormonal, bone-specific medicine, Fosamax has been studied in more than 17,000 patients in randomised clinical trials and prescribed for more than three million patients world-wide. Fosamax, like other bisphosphonates, should be used with caution in women with upper gastrointestinal disease. Patients with disorders of the esophagus that delay emptying, inability to stand or sit upright for at least 30 minutes, low levels of calcium in their blood, severe kidney disease, or who are pregnant or nursing should not take Fosamax. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, patients must take Fosamax upon arising for the day with a full glass of plain water (six to eight ounces). 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. Fosamax should not be taken at bedtime or before arising for the day. Patients should not chew or suck on the tablets. Fosamax was cleared by the United States Food and Drug Administration in 1995 for the treatment of osteoporosis in postmenopausal women (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 for osteoporosis and Fosamax (10 mg once-daily) was approved for the prevention of fractures in postmenopausal women who have osteoporosis. Related Links: Fosamax, Merck & Co., Inc.
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