Men Can Benefit from Alendronate
The two-year study, published in the Aug. 31 New England Journal of Medicine, reported that the bone mineral density of men taking 10 mg of alendronate daily increased as much as 5.3 percent over that of men taking placebo.
Less than 1 percent of patients taking alendronate had new vertebral fractures during the study, compared with 7.1 percent of men taking placebo. After two years, patients in the placebo group were, on average, 2.4 mm shorter than at the start of the study, but the height of men in the alendronate group was unchanged.
The 241 men who participated in the study were recruited from the United States and 10 other countries. Participants were 31 to 87 years old at baseline and almost exclusively white. All enrollees had primary osteoporosis or secondary osteoporosis resulting from low testosterone levels; men with other forms of secondary osteoporosis were excluded from the study.
Ninety-five men were randomly assigned to the placebo group, and 146 patients were treated with alendronate. Patients in both groups also received 500 mg of calcium carbonate and 400-450 IU of vitamin D each day. Eighty-three percent of the placebo group and 86 percent of the alendronate group completed the study.
Adverse effects, including gastrointestinal problems, occurred at similar rates in the two groups. Thirty-six percent of men in the placebo group and 41 percent of men in the alendronate group reported using a nonsteroidal anti-inflammatory drug during the study.
Increases in bone mineral density of the lumbar spine, hip, and total body were greatest during the first year of alendronate use. These changes were independent of patients age, smoking status, serum estradiol concentration, and serum free testosterone level. The change in density was greatest at the lumbar spine7.1 percent in alendronate-treated patients versus 1.8 percent in the placebo group. Total-body bone mineral density of alendronate-treated patients increased 1.6 percent over that of men treated with placebo.
Radiographs showed that about half of the enrollees had one or more vertebral fractures at baseline. Additional radiographs of the spine were obtained at the end of the study for 216 participants, and 209 films were suitable for quantitative analysis. Although patients who received alendronate had fewer vertebral fractures during the study period, fractures elsewhere in the body occurred at similar frequencies in both groups.
According to the authors, primary osteoporosis and osteoporosis caused by testosterone deficiency account for about 60 percent of all cases of osteoporosis among men. The results of the current study indicate that alendronate can effectively treat osteoporosis in these patients.
Alendronate, known by the brand name Fosamax, is manufactured by Merck & Co. Inc. The company funded this study, and nine of the 12 authors have served as consultants, been members of speakers bureaus for Merck, or owned stock in the company.
In 1999 the lead author, Eric Orwoll, M.D., was named principal investigator of a seven-center $23.8 million grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases to study osteoporosis in men.