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首页> 外文期刊>Expert opinion on pharmacotherapy >Good clinical endpoints with denosumab in osteoporosis and cancer.
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Good clinical endpoints with denosumab in osteoporosis and cancer.

机译：denosumab在骨质疏松症和癌症中的良好临床终点。

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BACKGROUND: Bone loss associated with low oestrogen levels in postmenopausal women, and with androgen deprivation therapy in men with hormone-sensitive prostate cancer, result in an increased incidence of fractures. Denosumab has been shown to increase bone mineral density in these two conditions. OBJECTIVES/METHODS: The objective of this evaluation is to review the clinical trials that have studied clinical endpoints in these conditions. RESULTS: FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) was an International Phase III clinical trial that measured the clinical endpoints with denosumab in postmenopausal women with osteoporosis. At 36 months, new vertebral fractures had occurred in 7.2% of subjects in the placebo group and this was lowered to 2.3% of subjects treated with denosumab. HALT (Denosumab Hormone Ablation Bone Loss Trial) studied the clinical endpoints in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. The incidence of vertebral fractures was significantly lower in the denosumab group (1.5%) than in the placebo group (3.9%). The incidence of adverse effects with denosumab in both clinical trials was low. CONCLUSIONS: Denosumab reduces the incidence of fractures in postmenopausal women with osteoporosis and in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. Denosumab is well tolerated.
机译：背景：绝经后妇女的骨质流失与雌激素水平低有关，而激素敏感性前列腺癌男性的雄激素剥夺疗法导致骨折的发生率增加。在这两种情况下，地诺单抗已显示可增加骨矿物质密度。目的/方法：这项评估的目的是回顾在这些情况下研究临床终点的临床试验。结果：自由（每6个月进行Denosumab骨质疏松症的骨折复位评估）是一项国际III期临床试验，该试验测量了绝经后骨质疏松症妇女的denosumab的临床终点。在第36个月时，安慰剂组中有7.2％的受试者发生了新的椎体骨折，而降到denosumab治疗组的2.3％。 HALT（Denosumab激素消融骨丢失试验）研究了接受雄激素剥夺治疗的非转移性前列腺癌男性的临床终点。地诺单抗组（1.5％）的椎体骨折发生率显着低于安慰剂组（3.9％）。在两个临床试验中，地诺单抗的不良反应发生率均较低。结论：地诺单抗降低了接受雄激素剥夺治疗的绝经后骨质疏松妇女和非转移性前列腺癌男性的骨折发生率。地诺单抗的耐受性良好。

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