United Osteoporosis Centers, Gainesville, Georgia; Medical College Jagiellonian University, Krakow, Poland; Michigan Bone and Mineral Clinic, Detroit, Michigan; the Clinical Research Center of North Texas, Denton, Texas; the University of Wisconsin-Madison Osteoporosis Clinical Center and Research Program, Madison, Wisconsin; the Palacios Institute of Woman's Health, Madrid, Spain; OB-GYN Associates of Mid Florida, PA, Leesburg, Florida; Amgen Inc, Thousand Oaks, California; Amgen Ltd, Cambridge, United Kingdom; Ovatech Solutions Ltd, London, United Kingdom; The Bethesda Health Research Center, Bethesda, Maryland; and Institut National de la Santé et de la Recherche Médicale (INSERM) U658, CHR d'Orléans, Orléans, France.
Obstet Gynecol. 2013 Jun;121(6):1291-1299. doi: 10.1097/AOG.0b013e318291718c.
To compare the efficacy and safety of denosumab to ibandronate in postmenopausal women with low bone mineral density (BMD) previously treated with a bisphosphonate.
In a randomized, open-label study, postmenopausal women received 60 mg denosumab subcutaneously every 6 months (n=417) or 150 mg ibandronate orally every month (n=416) for 12 months. End points included percentage change from baseline in total hip, femoral neck, and lumbar spine BMD at month 12 and percentage change from baseline in serum C-telopeptide at months 1 and 6 in a substudy.
At month 12, significantly greater BMD gains from baseline were observed with denosumab compared with ibandronate at the total hip (2.3% compared with 1.1%), femoral neck (1.7% compared with 0.7%), and lumbar spine (4.1% compared with 2.0%; treatment difference P<.001 at all sites). At month 1, median change in serum C-telopeptide from baseline was -81.1% with denosumab and -35.0% with ibandronate (P<.001); the treatment difference remained significant at month 6 (P<.001). Adverse events occurred in 245 (59.6%) denosumab-treated women and 230 (56.1%) ibandronate-treated women (P=.635). The incidence of serious adverse events was 9.5% for denosumab-treated women and 5.4% for ibandronate-treated women (P=.046). No clustering of events in any organ system accounted for the preponderance of these reports. The incidence rates of serious adverse events involving infection and malignancy were similar between treatment groups.
In postmenopausal women previously treated with a bisphosphonate and low BMD, denosumab treatment resulted in greater BMD increases than ibandronate at all measured sites. No new safety risks with denosumab treatment were identified.
比较绝经后骨质疏松症女性患者在接受双膦酸盐治疗后的低骨密度（BMD）情况下，地舒单抗与伊班膦酸盐的疗效和安全性。
在一项随机、开放标签的研究中，绝经后女性患者接受皮下注射地舒单抗 60mg，每 6 个月一次（n=417）或口服伊班膦酸 150mg，每月一次（n=416），共 12 个月。终点包括第 12 个月时总髋部、股骨颈和腰椎 BMD 与基线相比的变化百分比和亚研究中第 1 个月和第 6 个月时血清 C-端肽与基线相比的变化百分比。
第 12 个月时，与伊班膦酸盐相比，地舒单抗在总髋部（2.3%比 1.1%）、股骨颈（1.7%比 0.7%）和腰椎（4.1%比 2.0%；所有部位治疗差异 P<.001）的 BMD 增加更为显著。第 1 个月时，与基线相比，地舒单抗组血清 C-端肽中位数的变化为-81.1%，伊班膦酸盐组为-35.0%（P<.001）；第 6 个月时，治疗差异仍有显著意义（P<.001）。地舒单抗治疗组 245 名（59.6%）和伊班膦酸盐治疗组 230 名（56.1%）女性患者发生不良事件（P=.635）。地舒单抗治疗组严重不良事件发生率为 9.5%，伊班膦酸盐治疗组为 5.4%（P=.046）。没有任何器官系统的事件聚集解释这些报告的优势。涉及感染和恶性肿瘤的严重不良事件发生率在治疗组之间相似。
在接受过双膦酸盐治疗且 BMD 较低的绝经后女性患者中，地舒单抗治疗在所有测量部位的 BMD 增加均优于伊班膦酸盐。地舒单抗治疗未发现新的安全性风险。
