Stakkestad Jacob A, Lakatos Peter, Lorenc Roman, Sedarati Farhad, Neate Colin, Reginster Jean-Yves
CECOR AS, Nygårdsvegen 6, P.O. Box 1364 Gard, 5507, Haugesund, Norway.
Clin Rheumatol. 2008 Aug;27(8):955-60. doi: 10.1007/s10067-007-0824-6. Epub 2008 Jan 8.
Oral ibandronate is the first bisphosphonate licensed for once-monthly treatment of postmenopausal osteoporosis. The 2-year Monthly Oral iBandronate In LadiEs (MOBILE) registration study assessed bone mineral density (BMD) and markers of bone turnover and showed that monthly oral ibandronate was at least as effective and well tolerated as a 2.5-mg daily oral regimen. In this study, we report the first year of a long-term extension study to MOBILE and a post hoc analysis of patients receiving 3 years of continuous treatment with monthly ibandronate. Patients who completed MOBILE were eligible for the partially randomized, double-blind extension study and received 100 mg (n = 359) or 150 mg (n = 360) monthly oral ibandronate. A post hoc analysis included patients who received either 100 mg (n = 173) or 150 mg (n = 169) monthly ibandronate continuously throughout the original 2-year MOBILE study and during the first year of the extension study. After one additional year of treatment (total of 3 years), mean lumbar spine BMD increased a further 1.5 and 1.1% in the 150 and 100 mg arms, respectively, compared with 2-year data (original MOBILE study). Total hip BMD changed by 0.3 and -0.08%, respectively. In the post hoc analysis, 3-year increases in lumbar spine BMD were significant in patients receiving ibandronate 150 mg monthly (7.6%; p < 0.0001 vs. baseline) and 100 mg monthly (6.4%; p < 0.0001 vs. baseline). Both groups achieved significant increases in total hip BMD after 3 years compared with baseline (3.4%, 100 mg; 4.1%, 150 mg; p < 0.0001). Serum C-telopeptide of the alpha chain of type I collagen decreased significantly over 3 years' treatment (p < 0.001; all comparisons vs. baseline), remaining within the premenopausal range. Once-monthly oral ibandronate was well tolerated with a low incidence of clinical osteoporotic fractures and upper gastrointestinal events. In conclusion, 150-mg monthly oral ibandronate is an effective and well-tolerated long-term treatment for postmenopausal osteoporosis, with consistent improvement in BMD and bone turnover during 3 years' continuous treatment.
口服伊班膦酸盐是首个被批准用于每月一次治疗绝经后骨质疏松症的双膦酸盐药物。为期2年的“绝经后女性每月口服伊班膦酸盐（MOBILE）”注册研究评估了骨矿物质密度（BMD）和骨转换标志物，结果显示每月口服伊班膦酸盐至少与每日口服2.5毫克的治疗方案一样有效且耐受性良好。在本研究中，我们报告了MOBILE长期扩展研究的第一年情况以及对接受每月伊班膦酸盐连续治疗3年的患者进行的事后分析。完成MOBILE研究的患者有资格参加部分随机、双盲的扩展研究，并接受每月100毫克（n = 359）或150毫克（n = 360）的口服伊班膦酸盐治疗。事后分析纳入了在最初为期2年的MOBILE研究以及扩展研究的第一年中连续接受每月100毫克（n = 173）或150毫克（n = 169）伊班膦酸盐治疗的患者。在额外治疗一年（总共3年）后，与2年数据（原始MOBILE研究）相比，150毫克组和100毫克组的腰椎平均BMD分别进一步增加了1.5%和1.1%。全髋BMD分别变化了0.3%和 -0.08%。在事后分析中，接受每月150毫克伊班膦酸盐治疗的患者腰椎BMD 3年增加显著（7.6%；与基线相比p < 0.0001），接受每月100毫克治疗的患者也显著增加（6.4%；与基线相比p < 0.0001）。与基线相比，两组在3年后全髋BMD均显著增加（100毫克组为3.4%；150毫克组为4.1%；p < 0.0001）。在3年治疗期间，I型胶原α链血清C - 末端肽显著下降（p < 0.001；与基线的所有比较），仍处于绝经前范围内。每月一次口服伊班膦酸盐耐受性良好，临床骨质疏松性骨折和上消化道事件的发生率较低。总之，每月口服150毫克伊班膦酸盐是治疗绝经后骨质疏松症的一种有效且耐受性良好的长期治疗方法，在连续3年的治疗期间BMD和骨转换持续改善。
