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ENDO: Weekly Fosamax (Alendronate) Shows Equivalent Increases In Bone Density as Daily Regimen DENVER, CO -- June 20, 2001 -- Fosamax® (alendronate sodium), administered once weekly as a 70mg tablet in postmenopausal women with osteoporosis, built bone at the hip and spine to the same significant degree as the 10mg once-a-day regimen over a two-year period. The results from the one-year, double-blind extension of the original one-year multicenter study were presented today at The Endocrine Society Annual Meeting. "The study demonstrated that bone mineral density results with the once-weekly regimen were consistent with those on the once-daily regimen after two years. It confirms the results of the original one-year multicenter study in women being treated for osteoporosis," said Henry Bone, M.D., a lead investigator in the study and director, Michigan Bone and Mineral Clinic. Fosamax, a medicine from Merck & Co., Inc., is the first and only oral medication available in a once-weekly dosing regimen for the treatment (70mg) and prevention (35mg) of postmenopausal osteoporosis. Fosamax also is available in once-daily dosages for the treatment (10mg) and prevention (5mg) of postmenopausal osteoporosis. At the end of two years, increases in bone density at the spine were therapeutically equivalent with Fosamax 70mg once weekly and Fosamax 10mg once daily. The average percent increases from baseline in lumbar spine bone mineral density at the end of two years were 6.8 percent in the Fosamax 70mg once-weekly group and 7.4 percent in the Fosamax 10mg once-daily group. The 95 percent confidence interval (-1.1 to 0.1) on the average between-group difference of -0.5 indicated that both treatments produced comparable effects on bone mineral density after two years. Similarly, therapeutic equivalency results were shown for changes in bone mineral density at the hip and total body. Evaluation of the predefined endpoint of bone turnover markers, which are biochemical indicators of the rate of bone resorption (breakdown) and formation, showed similar changes across dosing regimens in the study. The overall safety and tolerability profiles, including the incidence of upper gastrointestinal (GI) adverse events seen in the study, were similar among the treatment regimens. Upper GI adverse events included esophageal, gastric or duodenal irritation or perforations, ulcers, and bleeding. The one-year extension of the double-blind, multi-center, one-year worldwide study included more than 85 percent of the 1,258 women originally enrolled. Women in the study were more than two years post menopause and had osteoporosis. Osteoporosis was defined as bone mineral density 2.5 standard deviations or more below the young adult mean at either the spine or hip, or a prior vertebral fracture or hip fracture. Women in the extension study received Fosamax 70mg once weekly (n=441), Fosamax 35mg twice weekly (n=317)(1) or Fosamax 10mg once daily (n=333). All groups received calcium and vitamin D supplements daily which is recommended practice in osteoporosis management. The primary endpoints of the study were change in bone mineral density at the lumbar spine and evaluation of safety and tolerability. Secondary endpoints included changes in bone mineral density at the hip and total body. Changes in bone mineral density at all sites were compared among treatment groups to determine if the effects of each group were equivalent based on equivalency criteria for the one year study. Fosamax, like other bisphosphonates, 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 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. The most commonly reported side effects with the Fosamax once-weekly or once-daily regimens have been abdominal pain, musculoskeletal pain, indigestion, regurgitation and nausea. Introduced in 1995 for the treatment of postmenopausal osteoporosis, Fosamax is the number one prescribed osteoporosis drug treatment in the United States(2). Fosamax also is approved for the treatment of Paget's disease of bone; the prevention of osteoporosis in postmenopausal women at risk of osteoporosis; a reduction in the incidence of hip and spine fractures in postmenopausal women who have osteoporosis; the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5mg or greater of prednisone and who have low bone mineral density; and the treatment to increase bone mass in men with osteoporosis. References: (1) Specific endpoint data not provided for the 35-mg treatment arm as this dosage is not the marketed dose for treatment of postmenopausal osteoporosis. (2) IMS HEALTH, National Prescription Audit(TM) and the National Disease and Therapeutic Index. Data are for Fosamax Once Weekly and Fosamax Once Daily for treatment of osteoporosis. Data are as of March 2001 (Moving Annual Total April 2000 through March 2001). SOURCE: Merck & Co., Inc. Related Links: Fosamax (alendronate sodium) and Merck & Co., Inc. E-mail this page to a friend or colleague! To print, use this version