Minodronate for the treatment of osteoporosis.

Minodronate, a new nitrogen-containing bisphosphonate, was developed in Japan. It was the first drug to demonstrate significant prevention of vertebral fractures in Japanese patients with osteoporosis in a phase III doubleblind comparative study. As a result of positive data from clinical trials in Japan minodronate was granted a Japanese marketing approval for the treatment of osteoporosis on January 21, 2009. In vitro studies demonstrated that minodronate is one of the most potent inhibitors of bone resorption among currently available bisphosphonates. Preclinical studies demonstrated the inhibitory effect of minodronate on the decrease in the bone mineral density (BMD) in ovariectomized rats, dogs and monkeys. Daily oral minodronate was safe, well tolerated and effective in reducing vertebral fracture risk in postmenopausal women with established osteoporosis. The effects on lumbar and hip BMD and the safety profile of minodronate are comparable to those of alendronate. These data suggest that minodronate is a promising new potent bisphosphonate for the treatment of osteoporosis.