Fractures in men with osteoporosis are reduced following treatment with alendronate (Fosamax), researchers have found.
According to the results of an international double blind trial, alendronate significantly increases spine, hip and total-body bone mineral density and helps to prevent vertebral fractures and decreases in height (New England Journal of Medicine 2000;343:604).
In the study, 241 men with osteoporosis were randomly assigned to receive either alendronate 10mg daily or placebo for up to two years. Both groups received calcium and vitamin D supplements throughout the trial.
After two years of treatment, men who received alendronate had a mean increase in bone mineral density of 7.1 per cent at the lumbar spine, 2.5 per cent at the femoral neck of the hip and 2.0 per cent for the total body. Men who received placebo had an increase in bone mineral density of 1.8 per cent at the lumbar spine and 0.4 per cent for the total body. There was a decrease in bone mineral density of 0.1 per cent at the femoral neck of the hip in the placebo group. The effects on bone mineral density were independent of age and were seen in both androgen-deficient men and those with normal testosterone levels, say the researchers.
Treatment with alendronate also decreased height loss. The decrease observed for men in the treatment group was 0.6mm compared with 2.4mm for men receiving placebo. In addition, the incidence of new spinal fractures was reduced by 89 per cent after two years treatment with alendronate, say the researchers. A total of 7.1 per cent of patients receiving placebo experienced a new vertebral fracture compared with 0.8 per cent of patients in the alendronate group (p=0.02).
Commenting on the results, Dr Eric Orwoll (professor of medicine, Oregon Health Sciences University, US, and lead author of the study) said: "Because of the myth that osteoporosis only affects women, many men who are at risk for the disease are not diagnosed until they experience a significant loss of height or back pain due to compression fractures in the spine, or they break a hip." He added: "Osteoporosis can be even more devastating in men than in women. Although a man is about half as likely as a woman to suffer a broken hip, he is nearly twice as likely to die the year following a hip fracture."
The trial was supported by a grant from Merck Sharp & Dohme (manufacturer of Fosamax). In a press release on August 31, MSD announced its submission of applications to regulatory agencies worldwide for approval to market Fosamax for the treatment of osteoporosis in men.