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J Clin Endocrinol Metab:长期地诺单抗治疗可降低骨质疏松相关的非椎骨骨折风险

2020-06-28 MedSci原创 MedSci原创

当前缺乏长期的抗吸收治疗骨质疏松症进一步减少非椎骨骨折(NVF)的证据。评估接受地诺单抗治疗≤10年的受试者的NVF风险降低。

当前缺乏长期的抗吸收治疗骨质疏松症进一步减少非椎骨骨折(NVF)的证据。评估接受地诺单抗治疗≤10年的受试者的NVF风险降低。

 

每6个月(FREEDOM)试验(NCT00089791)及其在患者体内进行7年开放标签(NCT00523341)的Denosumab治疗骨质疏松症的3期随机,安慰剂对照,3年骨折减少评估。

 

在全球一百七十二个学习中心,纳入 60至90岁的女性,腰椎或总髋骨矿物质密度T分数<-2.5(两者均≥-4.0)。受试者随机分配1:1地诺单抗60 mg SC Q6M(长期)或安慰剂(交叉);符合条件的受试者可以参加扩展,以接受denosumab 60 mg SC Q6M。

 

地诺单抗治疗1-3和4-7年(所有受试者)和4-10年(仅长期)的NVF暴露校正后受试者发生率(每100个受试者年),以及4-7或4-10 VS 1-3年的比率(RR)。

 

结果显示,在4074名受试者(长期2343名,1731名交叉研究)中,所有受试者的NVF率(95%CI)在denosumab治疗的1-3年期间为2.15(1.90至2.43),在4-7年期间为1.53(1.34至1.75)[RR(95%CI)= 0.72(0.61至0.86); P <0.001];仅长期而言,在1-3年期间为1.98(1.67至2.34),在4-10年期间为1.44(1.24至1.66)[RR = 0.74(0.60至0.93); P = 0.008]。合并颌骨坏死和非典型股骨骨折的发生率为0.06。

 

综上所述,该研究结果表明,与头三年相比,长期地诺单抗治疗> 3年且≤10年与NVF率进一步降低有关。

 

原始出处:

 

Serge FerrariPeter W Butler, et al., Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3450-3461.

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    2020-09-10 一闲
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    2021-03-13 guojianrong
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    2020-06-30 Eleven17

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