一种使用针对核因子κB受体活化因子配体（RANKL）的全人源单克隆抗体AMG 162治疗骨质疏松症的新方法
[A new treatment for osteoporosis using fully human monoclonal antibody to RANKL, AMG 162].
作者信息
Takahashi Naoyuki, Ozawa Hidehiro
机构信息
Department of Hard Tissue Research, Graduate School of Oral Science Course, Matsumoto Dental University, Japan.
出版信息
Clin Calcium. 2005 Jan;15(1):43-8.
RANKL is an essential factor for osteoclastogenesis. Amgen research group has developed AMG 162, a fully human monoclonal antibody to RANKL. The bone antiresorptive activity and safety of AMG 162 were evaluated in 49 healthy postmenopausal women (Phase I study). The effect of increasing amounts of AMG 162 on bone mineral density (BMD) was studied in 411 postmenopausal women with low BMD (Phase II study). A single subcutaneous dose of AMG 162 (1 mg/kg or 60 mg) suppressed bone resorption for more than 6 month without critical side effects (Phase I study), and increased BMD within 1 month in postmenopausal women (Phase II study).
核因子κB受体活化因子配体（RANKL）是破骨细胞生成的关键因素。安进研究小组研发了AMG 162，一种针对RANKL的全人源单克隆抗体。在49名健康绝经后女性中评估了AMG 162的抗骨吸收活性和安全性（I期研究）。在411名低骨密度绝经后女性中研究了不同剂量的AMG 162对骨矿物质密度（BMD）的影响（II期研究）。单次皮下注射AMG 162（1毫克/千克或60毫克）可抑制骨吸收超过6个月且无严重副作用（I期研究），并可使绝经后女性在1个月内骨密度增加（II期研究）。
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