JCEM:Abaloparatide增加骨质疏松患者的腰椎和髋关节骨密度

2022-08-20 医路坦克 MedSci原创

Abaloparatide是一种人工合成的甲状旁腺激素相关肽(PTHrP)类似物,本研究的主要目的是确定自身皮下注射Abaloparatide与安慰剂相比,对骨折风险较高的日本老年骨质疏松症患者增加骨

Abaloparatide是一种人工合成的甲状旁腺激素相关肽(PTHrP)类似物,在PTHrP的22-31位之间发生氨基酸取代。体外研究表明,至少存在两种甲状旁腺素受体1型(PTH1R)构象:R0和RG。当配体与PTH1R的RG构象结合时,Gs蛋白被招募,促进配体的释放,导致细胞内环磷酸腺苷(CAMP)的一过性增加。相反,当配体与PTH1R的R0构象结合时,cAMP反应延长。Abaloparatide与PTH1R的R0构象结合亲和力较低,而与RG构象结合的亲和力与PTH相似。因此,与甲状旁腺素)相比,Abaloparatide促进了更短暂的信号传递,导致了更高的合成代谢效应,但对骨吸收的促进作用较小。

在全球3期Abaloparatide椎体终点比较试验中,Abaloparatide还显示出对骨形成和吸收的刺激作用,与安慰剂和Teriparatide相比,对骨骼的合成代谢作用更明显,但纳入的亚洲患者很少。在一项涉及日本有高骨折风险的绝经后妇女的2期剂量-反应研究中,每天注射80微克Abaloparatide耐受性良好,并导致与剂量相关的骨密度(BMD)增加。因此,本研究的主要目的是确定自身皮下注射Abaloparatide与安慰剂相比,对骨折风险较高的日本老年骨质疏松症患者增加骨密度的有效性和安全性。

设计:随机、双盲、安慰剂对照研究。绝经后有高骨折风险的骨质疏松女性和男性每天皮下注射80微克Abaloparatide或安慰剂,为期78周(18个月)。主要终点是腰椎(LS)骨密度较上次就诊时基线的百分比变化。次要终点包括LS、全髋关节(TH)和股骨颈(FN)BMDS、骨转换标志和累积骨折数的时程变化。

结果:与安慰剂组相比,Abaloparatide使LS、TH和FN骨密度(平均[95%CI])分别增加12.5%(10.3%~14.8%;p<0.001)、4.3%(3.3%~5.3%)和4.3%(2.9%~5.6%)。血清PINP在6周时迅速升高至较基线水平约140%,然后逐渐下降,但在78周时较基线水平升高约25%。血清CTX在24周时逐渐上升到基线水平的50%,并从60周开始逐渐下降到安慰剂组水平。安慰剂组的三个参与者的四个椎体发生了新的椎体骨折,而阿巴拉替丁组没有出现新的椎体骨折。安全性描述与积极研究中的相似。

腰椎、全髋关节和股骨颈骨密度较基线的百分比变化。骨密度较基线的平均百分比变化:(A)腰椎、(B)全髋部和(C)股骨颈。对每个治疗组在每个评估时间点的观察值和较基线的百分比变化进行描述性统计分析,而不计算完整分析集中的缺失数据。数据是以具有标准差的平均值表示的。比较采用学生t检验。这些分析是探索性的,没有对多样性进行调整。*Abaloparatide与安慰剂比较P<0.001。骨密度、骨密度。

治疗组血清骨代谢标记物随时间变化的中位数。(A)血清I型前胶原N末端前肽、(B)血清I型胶原羧基末端交联末端肽、(C)血清骨钙素和(D)血清抗酒石酸酸性磷酸酶5b的中位数百分比变化。误差条表示四分位数的中位数范围。比较采用Wilcoxon秩和检验。这些分析是探索性的,没有对多样性进行调整。*Abaloparatide与安慰剂比较P<0.001;Abaloparatide与安慰剂比较P<0.05。CTX,I型胶原的羧基末端交联端肽;OCN,骨钙素;PINP,I型前胶原N末端前肽;TRACP-5b,耐酒石酸酸性磷酸酶5b。

结论:在日本绝经后骨质疏松症患者和有高骨折风险的男性患者中,Abaloparatide78周显著增加LS、TH和FN BMDS,这表明在日本患者和积极研究人群中具有类似的疗效。

文献来源:Matsumoto T,  Sone T,  Soen S,Abaloparatide Increases Lumbar Spine and Hip BMD in Japanese Patients With Osteoporosis: The Phase 3 ACTIVE-J Study.J Clin Endocrinol Metab 2022 Aug 17; 

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    2022-11-01 smallant2015
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    2023-06-06 achengzhao
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    2022-09-07 146480bem82暂无昵称

    缺乏有效的锻炼身体的方式,饮食结构,都影响骨质疏松。

    0

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    2022-08-29 循证小兵

    #Abaloparatide#增加#骨质疏松#患者的腰椎和髋关节#骨密度#

    0

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    2022-08-20 Eleven17

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