[Therapeutic agents for disorders of bone and calcium metabolism: Ibandronate].
Ibandronate is a potent nitrogen-containing bisphosphonate that can be administered by short (15 - 30 second) intravenous (i.v.) injection in regimens with extended dosing intervals; unlike in Caucasian women, the efficacy and safety of this formulation is yet to be fully explored in Japanese with osteoporosis. A 6-month, multicenter, randomized, double-blind, placebo-controlled study, involving 228 Japanese women with osteoporosis, was conducted to compare the efficacy and safety of the i.v. injection regimens. At 6 months, substantial increases in bone mineral density (BMD) were observed at the lumbar spine and proximal femur in the active treatment arms. For biochemical markers of bone turnover (urinary type I collagen cross linked C-terminal telopeptide [uCTX] and bone alkaline phosphatase [BAP]), the 1 mg monthly and 2 mg bi-monthly regimens were nominally more effective than the 0.5 mg monthly regimen; all ibandronate regimens were superior to placebo. The i.v. ibandronate injections were generally well tolerated, with a similar overall adverse event profile to placebo. No serious drug-related adverse events were reported. Monthly and bi-monthly i.v. ibandronate injections effectively reduce bone turnover and increase BMD in Japanese women with osteoporosis. Ibandronate injections provide a new option for the treatment of osteoporosis.
Hashimoto
Junko
J
Chugai Pharmaceutical Co. Ltd., Strategic Marketing Unit, Bone Disease Area Department.
D000284:Administration, Oral; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D004164:Diphosphonates / Q000008:administration & dosage*; D005060:Europe; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D007275:Injections, Intravenous; D007564:Japan; D010024:Osteoporosis / Q000188:drug therapy*; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic; D014481:United States
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid