Targeted approaches in the treatment of osteoporosis: differential mechanism of action of denosumab and clinical utility.
Targeted approaches in the treatment of osteoporosis: differential mechanism of action of denosumab and clinical utility.
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DOI：
10.2147/tcrm.s7688
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发表时间：
2012
影响因子：
2.8
通讯作者：
Brandi ML
中科院分区：
文献类型：
--
作者：
Cavalli L;Brandi ML
狄诺塞麦是美国食品药品监督管理局和欧洲药品管理局于2010年批准用于治疗骨质疏松症的突破性生物药。它是一种全人源单克隆抗核因子κ-B配体抗体激活剂，可抑制破骨细胞的活性，产生抗骨吸收作用，并显着增加骨密度。 FREEDOM（每 6 个月对地诺单抗治疗骨质疏松症进行骨折减少评估）试验对 7868 名绝经后骨质疏松症女性进行了地诺单抗与未治疗的比较，结果显示治疗组髋部、椎骨和非椎体部位的骨折风险显着降低，而地诺单抗组和安慰剂组之间的不良事件发生率没有检测到统计学上的显着差异。狄诺塞麦针对破骨细胞关键调节因子的特异性作用使其成为预防晚期恶性肿瘤患者因骨质破坏引起的骨骼事件发生的宝贵工具。该药物被批准用于治疗骨折风险增加的女性绝经后骨质疏松症，以及治疗男性前列腺癌患者与雄激素剥夺疗法相关的骨质流失。
Denosumab is a breakthrough biological drug approved by the Food and Drug Administration and European Medicines Agency for the treatment of osteoporosis in 2010. It is a fully human monoclonal antireceptor activator of nuclear factor kappa-B ligand antibody, which inhibits the activity of osteoclasts, resulting in an antiresorptive effect with a significant increase in bone mineral density. The FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial, comparing denosumab with no treatment in 7868 women with postmenopausal osteoporosis, showed an important reduction of fracture risk at hip, vertebral, and nonvertebral sites in the treated group, while no statistically significant difference in the incidence of adverse events was detected between denosumab and placebo groups. The specific action of denosumab directed against a key regulator of osteoclasts makes it a valuable tool in preventing the occurrence of skeletal events caused by bone destruction in patients with advanced malignancies. The drug was approved for postmenopausal osteoporosis in women at increased risk of fracture and for the treatment of bone loss associated with androgen deprivation therapy in men with prostate cancer.