[Therapeutic agents for disorders of bone and calcium metabolism: Minodronic acid hydrate].
Minodronic acid hydrate is one of the new-generation bisphosphonates containing nitrogen. This drug has an inhibitory effect on bone resorption by suppressing the osteoclastic function, and it is being developed as a therapeutic drug of osteoporosis. In non-clinical study, the drug has an inhibitory effect on the decrease of the bone mineral density and the bone intensity in ovariectomized rat osteoporosis models. The one of two Phase III studies, conducted so far, indicated that minodronic acid hydrate, administered once daily for 104 weeks, reduced the risk of vertebral fracture compared to placebo in postmenopausal Japanese women with osteoporosis. The other study conducted that minodronic acid hydrate increases the bone mineral density at least equivalent to that of alendronate for 48 weeks. The safety analysis in the latest study revealed that the adverse events of minodoronic acid hydrate have no statistically significant differences from the placebo group. We expect that minodronic acid hydrate will be used for a number of patients with osteoporosis as a potent and safe domestically created bisphosphonate in the near future.
Miki
Takashi
T
Ono Pharmaceutical Co., Ltd., Clinical Planning III Development Planning.
Minamide
Toshiomi
T
D000818:Animals; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001862:Bone Resorption / Q000188:drug therapy; D002986:Clinical Trials as Topic; D004164:Diphosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000494:pharmacology / Q000627:therapeutic use*; D010010:Osteoclasts / Q000187:drug effects; D010024:Osteoporosis / Q000188:drug therapy* / Q000503:physiopathology; D051381:Rats; D016103:Spinal Fractures / Q000517:prevention & control
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; C087958:YM 529