Aro Hannu T, Nazari-Farsani Sanaz, Vuopio Mia, Löyttyniemi Eliisa, Mattila Kimmo
Departments of Orthopaedic Surgery and Traumatology Turku University Hospital and University of Turku Turku Finland.
Unit of Biostatistics, Department of Clinical Medicine University of Turku Turku Finland.
JBMR Plus. 2019 Aug 14;3(10):e10217. doi: 10.1002/jbm4.10217. eCollection 2019 Oct.
Antiresorptive denosumab is known to improve the quality and strength of cortical bone in the proximal femurs of osteoporotic women, but its efficacy in preventing periprosthetic bone loss and reducing femoral stem migration has not been studied in women undergoing cementless total hip arthroplasty. We conducted a single-center, randomized, double-blinded, placebo-controlled trial of 65 postmenopausal women with primary hip osteoarthritis and Dorr type A or B proximal femur anatomy. The patients randomly received subcutaneous injections of denosumab 60 mg or placebo once every 6 months for 12 months, starting 1 month before surgery. The primary endpoint was the change in bone mineral density (BMD) of the proximal femur (Gruen zone 7) at week 48, and the secondary endpoint was stem subsidence measured by radiostereometric analysis (RSA) at week 48. Exploratory endpoints included changes in BMDs of the contralateral hip, lumbar spine and distal radius, serum levels of bone turnover markers, walking speed, walking activity, patient-reported outcome measures, and radiographic assessment of stem osseointegration. The participants underwent vertebral-fracture assessment in an extension safety study at 3 years. Denosumab significantly decreased bone loss in the medial femoral neck (zone 7) and increased periprosthetic BMD in the greater trochanteric region (zone 1) and lesser trochanteric region (zone 6). Denosumab did not reduce temporary femoral stem migration. The migration occurred mainly during the settling period (0 to 12 weeks) after implantation of the prosthesis. All of the stems osseointegrated, as evaluated by RSA and radiographs. There were no intergroup differences in functional recovery. Discontinuation of denosumab did not lead to any adverse events. In conclusion, denosumab increased periprosthetic BMD in the clinically relevant regions of the proximal femur, but the treatment response was not associated with any reduction of initial stem migration. © 2019 The Authors. published by Wiley Periodicals, Inc. on behalf of the American Society for Bone and Mineral Research.
抗吸收药物地诺单抗已知可改善骨质疏松女性股骨近端皮质骨的质量和强度，但在接受非骨水泥全髋关节置换术的女性中，其预防假体周围骨丢失和减少股骨干迁移的疗效尚未得到研究。我们对65例患有原发性髋骨关节炎且股骨近端解剖结构为多氏A或B型的绝经后女性进行了一项单中心、随机、双盲、安慰剂对照试验。患者在手术前1个月开始，每6个月皮下注射一次60 mg地诺单抗或安慰剂，共注射12个月。主要终点是第48周时股骨近端（Gruen 7区）骨矿物质密度（BMD）的变化，次要终点是第48周时通过放射立体测量分析（RSA）测量的假体下沉。探索性终点包括对侧髋部、腰椎和桡骨远端BMD的变化、骨转换标志物的血清水平、步行速度、步行活动、患者报告的结局指标以及假体骨整合的影像学评估。在一项为期3年的扩展安全性研究中，参与者接受了椎体骨折评估。地诺单抗显著减少了股骨内侧颈（7区）的骨丢失，并增加了大转子区域（1区）和小转子区域（6区）的假体周围BMD。地诺单抗并未减少股骨干的临时迁移。迁移主要发生在假体植入后的沉降期（0至12周）。通过RSA和X线片评估，所有假体均实现了骨整合。功能恢复方面，组间无差异。停用 地诺单抗未导致任何不良事件。总之，地诺单抗增加了股骨近端临床相关区域的假体周围BMD，但治疗反应与初始假体迁移的减少无关。© 2019作者。由Wiley Periodicals, Inc.代表美国骨与矿物质研究学会出版。
