| Objectives To review the efficacy and safety of ibandronate (injection and tablet) in the treatment of postmenopausal osteoporosis.Methods Electronic searches (up to March 2007) were conducted in the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (up to issue 3, 2006), MEDLINE (1956-2007) and EMBASE (1996-2007). There was no restriction of language. Randomized control trials that included participants with postmenopausal osteoporosis and compared ibandronate (tablets and injection) with placebo or other anti-reabsorption drugs were included in this systematic review.Results 11 randomized controlled trials and 9933 participants with postmenopausal osteoporosis were included. Methodological quality of 9 trials were A and that of the rest 2 trials were B. Continuous oral ibandronate (2.5 mg/day) and intermittent ibandronate significantly reduced the risk of vertebral fractures (62% and 50%, respectively). The oral daily ibandronate also had a significant and sustained reduction of the risk of new moderate and severe vertebral fractures and was observed at years 1 (P=0.0164), 2(P=0.0004), and 3 (P<0.0001). There was no significant difference on reduction of nonvertebral fractures between oral ibandronate and placebo. But pronounce effect aroused in the subgroup of participants with a lower T score (<-3.0 SD). Both continuous and intermittent therapy of lbandronate can significantly increase the bone mineral density (BMD) at lumbar spine [WMD 3.32, 95%CI (2.05, 4.59) and WMD 3.26, 95%CI (1.90, 4.62), respectively]. No significant difference was detected between oral daily ibandronate group and intermittent ibandronate group at a small dose(≤100 mg/month) [WMD -0.50, 95%CI (-1.21, 0.21)], however a larger dose of 150 mg/month showed a better effect (BMD at lumbar spine p < 0.001, BMD at all site of hip p < 0.05). Small dose of ibandronate injection did not have a better effect in reduction of fractures than placebo. Ibandronate injection at all dosage can significantly increase the lumbar spine and hip BMD and a dose-effect relationship appeared. A larger dose of ibandronate injection (2-3 mg/3 months) had a better effect in increasing BMD than oral ibandronate (P<0.001) but they were not statistically different in reduction the risk of fractures. Both oral and intravenous ibandronate were safe and well tolerated by the participants.Conclusion There is "platinum" level of evidence that oral ibandronate significantly reduced the vertebral fracture relative to postmenopausal osteoporosis. The effect of intravenous ibandronate injection on fractures was still unclear. Both oral and intravenous ibandronate had a good effect on BMD of participants with postmenopausal osteoporosis. Ibandronate was safe and well tolerated. More large, high-quality RCTs are needed to assess the effect and safety of intermittent oral and intravenous therapy of ibandronate at a large dose on reduction of postmenopausal osteoporotic fractures, especially in participants with different level of BMD.
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