[Therapeutic agents for disorders of bone and calcium metabolism: Ibandronate]. [Article in Japanese]
Author(s): Hashimoto J(1).
Affiliation(s): Author information:
(1)Chugai Pharmaceutical Co. Ltd., Strategic Marketing Unit, Bone Disease Area
Department.
Publication date & source: 2007, Clin Calcium. , 17(1):11-7
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.
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