Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis.

摘要: Oral daily (2.5 mg) and intermittent ibandronate (between-dose interval of >2 months), delivering a similar cumulative exposure, were evaluated in 2946 osteoporotic women with prevalent vertebral fracture. Significant reduction incident fracture risk by 62% 50%, respectively, was shown after 3 years. This is the first study to prospectively show antifracture efficacy for adminis- tration bisphosphonate. Introduction: Bisphosphonates are important therapeutics postmenopausal osteoporosis. However, they currently associated stringent dosing instructions that may impair patient compliance hence therapeutic efficacy. Less frequent, administration help overcome these deficiencies. assessed safety oral administered either or intermittently dose-free 2 months. Materials Methods: randomized, double-blind, placebo-controlled, parallel-group enrolled post- menopausal BMD T score 2.0 at lumbar spine least one vertebra (L1-L4) four fractures (T4-L4). Patients received placebo (20 mg every other day 12 doses months). Results Conclusions: After years, rate new significantly reduced patients receiving (4.7%) (4.9%), relative (9.6%). Thus, morphometric (p 0.0001) 50% 0.0006), versus placebo. Both treatment groups also produced statistically significant clinical (49% 48% ibandronate, respectively). progressive increases (6.5%, 5.7%, 1.3% placebo, years) hip BMD, normalization bone turnover, less height loss than group observed both regimens. The overall population low fractures. Consequently, incidence nonvertebral between years (9.1%, 8.9%, 8.2% daily, intermittent, groups, respectively; difference arms not significant). findings from posthoc analysis showed regimen reduces (69%; p 0.012) higher-risk subgroup (femoral neck 3.0). In addition, well tolerated. whether an extended between-dose months, highly effective reducing women. time has been bisphos- phonate controlled trial. holds promise as convenient alternative current bisphosphonate therapies. J Bone Miner Res 2004;19:1241-1249. Published online on March 29, 2004; doi: 10.1359/JBMR.040325