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To: Anthony Wong who wrote (1017)	11/10/1998 2:44:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 1722

[MRK] ACR MEETING: Fosamax Increased Bone Mass In Men Taking Chronic Glucocorticoids SAN DIEGO, CA -- Nov. 10, 1998 -- New data presented today at the annual meeting of the American College of Rheumatology showed the investigational use of Fosamax® (alendronate sodium) in men stopped bone loss and increased bone mineral density (BMD) at the spine and hip, two common sites of osteoporotic fracture. The men in the study all were at risk of osteoporosis and future fracture due to chronic use of glucocorticoids (commonly referred to as corticosteroids, or steroids). "Previous studies have shown Fosamax to be effective in treating and preventing osteoporosis in postmenopausal women," said Barry Gruber, M.D., director of the Osteoporosis Center and division head of rheumatology at the State University of New York (SUNY), Stonybrook. "These new data are important because they looked at the effectiveness and safety of Fosamax in treating and preventing bone loss in men, as well as women, who are on long-term glucocorticoid therapy." Although osteoporosis is commonly thought of as a disease of postmenopausal women, 20 percent of those who have osteoporosis are men -- many due to glucocorticoid use. Yet currently there are no medications approved by the U.S. Food and Drug Administration (FDA) to prevent or treat osteoporosis in men. Bone loss leading to osteoporosis is one of the most debilitating effects of long-term treatment with prednisone and other glucocorticoids in the men and women who take these drugs for chronic conditions such as rheumatologic and pulmonary diseases. More than 1 million Americans are estimated to use glucocorticoids to manage conditions including asthma, chronic lung disease, rheumatoid arthritis, connective tissue disease, inflammatory bowel disease and organ transplantation. Early intervention to prevent bone loss is critical because glucocorticoid users can lose large amounts of bone rapidly -- as much as 20 percent in the first year of treatment alone. Bone loss from long-term glucocorticoid therapy ultimately leads to osteoporosis and resulting fractures in an estimated 30 percent to 50 percent of patients. The results reported by Dr. Gruber came from an analysis of data from a sub-population of 141 men aged 22 to 79 years from two double-blind 48-week studies of 477 men and women receiving at least 7.5 mg of steroids (prednisone or equivalent) daily. Patients in the two studies were randomized to placebo, Fosamax 5 mg once-daily, or Fosamax 10 mg once-daily. All 477 patients were supplemented with recommended daily levels of calcium and vitamin D. At the end of 48 weeks, use of Fosamax (5 mg and 10 mg) prevented bone loss at the spine and hip. Men on placebo lost bone relative to baseline at these sites. The statistically significant mean changes in BMD at these sites relative to baseline were: -- Lumbar spine: a 3.4 percent and 2.9 percent increase for Fosamax 5 mg and 10 mg, respectively. -- Femoral neck: a 2.2 percent increase for Fosamax 10 mg versus a 1.6 percent decrease for placebo. -- Trochanter: a 2.7 percent increase for Fosamax 10 mg versus a 1.3 percent decrease for placebo. "The results of this investigational study showed that use of Fosamax was well tolerated and may be of benefit in protecting against the debilitating bone loss that is a common side effect of glucocorticoid therapy," reported Dr. Gruber. "Moreover, as witnessed by the bone loss in the placebo group, calcium and vitamin D supplementation alone were not sufficient to prevent such bone loss." Other Data Analyses Showed Consistency of Effect with Fosamax Other data analyses also released at the American College of Rheumatology meeting this week from the two studies of 477 men and women using glucocorticoids found that: -- Use of Fosamax in patients on chronic glucocorticoid therapy resulted in consistent gains in spinal BMD regardless of other concomitant medication and underlying disease state requiring glucocorticoid therapy. -- BMD increases at the hip and spine in men and women who were administered Fosamax for glucocorticoid-induced osteoporosis were consistent with bone mass increases observed at one year in the vertebral fracture arm of the Fracture Intervention Trial (FIT). In FIT, 2,027 postmenopausal women with osteoporosis and a prior vertebral fracture were administered Fosamax (5 mg once-daily) for the first two years of the study followed by Fosamax (10 mg once-daily) for the third year of the study.