Division of Rheumatology, Azienda Sanitaria Genovese, Genoa, Italy.
Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.
Long-term bone mineral density (BMD) gains, bone marker levels, and safety of 3 mg quarterly intravenous (IV) ibandronate were studied in this 3-year extension to the Dosing IntraVenous Administration (DIVA) trial. Quarterly IV ibandronate consistently increased lumbar spine bone mineral density measured with dual-energy X-ray absorptiometry (DXA-BMD) over 5 years (8.1%) and was well tolerated in women with postmenopausal osteoporosis.
Treatment with IV ibandronate regimens, 2 mg bimonthly and 3 mg quarterly, has been studied for up to 5 years in a long-term extension (LTE) to the 2-year DIVA trial.
DIVA LTE is an open-label extension to a 2-year randomized, double-blind, double-dummy, noninferiority, phase III study (DIVA core). DIVA LTE involved postmenopausal women who had completed 2 years of DIVA core, comparing daily oral and IV ibandronate (≥75% adherence with IV ibandronate in year 2 of DIVA). Patients previously treated with 2 mg bimonthly or 3 mg quarterly IV ibandronate continued on the same regimen; patients who had received 2.5 mg daily oral ibandronate and placebo IV in DIVA core were switched to IV ibandronate.
Pooled analysis of 497 intent-to-treat (ITT) patients receiving IV ibandronate from DIVA core baseline showed consistent increases over 5 years in lumbar spine DXA-BMD (8.4% [95% confidence interval (CI) = 7.5, 9.3] with 2 mg bimonthly and 8.1% [95% CI = 7.2, 8.9] with 3 mg quarterly). Three-year data relative to DIVA LTE baseline in the full ITT population (756 patients randomized or reallocated from DIVA, including those previously on daily treatment) showed maintenance of DXA-BMD gains from DIVA core with further gains in lumbar spine DXA-BMD. These benefits are supported by sustained reductions in markers of bone metabolism. No tolerability concerns or new safety signals were observed.
Treatment with IV ibandronate 2 mg bimonthly or 3 mg quarterly is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.
本研究为剂量静脉内给药（DIVA）试验的 3 年延伸，旨在研究每季度静脉注射（IV）伊班膦酸盐 3 毫克的长期骨矿物质密度（BMD）增加、骨标志物水平和安全性。3 毫克每季度的 IV 伊班膦酸盐在 5 年内持续增加腰椎骨矿物质密度（DXA-BMD），（通过双能 X 射线吸收法（DXA-BMD）测量）（8.1%），且在绝经后骨质疏松症女性中耐受性良好。
为期 5 年的长期扩展（LTE）至 2 年 DIVA 试验中，已对 2 毫克每两个月和 3 毫克每季度的 IV 伊班膦酸盐方案进行了治疗。
DIVA LTE 是一项为期 2 年的随机、双盲、双模拟、非劣效性、III 期研究（DIVA 核心）的开放标签延伸。DIVA LTE 涉及已完成 2 年 DIVA 核心的绝经后妇女，比较了每日口服和 IV 伊班膦酸盐（在 DIVA 核心的第 2 年，IV 伊班膦酸盐的依从率≥75%）。以前接受过 2 毫克每两个月或 3 毫克每季度 IV 伊班膦酸盐治疗的患者继续接受相同的方案；在 DIVA 核心中接受过 2.5 毫克每日口服伊班膦酸盐和安慰剂 IV 的患者转为 IV 伊班膦酸盐。
来自 DIVA 核心基线的 497 名意向治疗（ITT）患者的汇总分析显示，5 年内腰椎 DXA-BMD 持续增加（2 毫克每两个月组为 8.4%（95%置信区间（CI）=7.5，9.3），3 毫克每季度组为 8.1%（95%CI=7.2，8.9））。在全部 ITT 人群（756 名从 DIVA 随机或重新分配的患者，包括以前接受每日治疗的患者）中，与 DIVA LTE 基线相比，3 年数据显示腰椎 DXA-BMD 持续增加，且 DXA-BMD 进一步增加。这些益处得到了骨代谢标志物持续减少的支持。未观察到耐受性问题或新的安全性信号。
在绝经后骨质疏松症女性中，每 2 个月静脉注射 2 毫克或每季度静脉注射 3 毫克伊班膦酸盐治疗 5 年是有效且耐受性良好的。
