Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study.
Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study.
复制标题
在骨质疏松患者中，使用有或没有双膦酸盐预处理的denosumab使用denosumab的血清维生素D和PTH值的变化：一项短期研究。
DOI：
10.1186/s12902-015-0077-3
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发表时间：
2015-12-15
影响因子：
2.7
通讯作者：
Kato H
中科院分区：
文献类型：
--
作者：
Nakamura Y;Kamimura M;Ikegami S;Mukaiyama K;Uchiyama S;Taguchi A;Kato H
Denosumab是一种全人源单克隆抗体，可抑制核因子κ-β配体受体激活因子（RANKL）。既往报告显示，地舒单抗治疗可降低骨质疏松患者的骨吸收和骨折风险，但在日本，尚无关于地舒单抗治疗联合或不联合双膦酸盐（BP）预治疗时骨转换标志物1，25（OH）2D 3或甲状旁腺激素（PTH）变化的临床研究。在此，我们报告了22例骨质疏松患者（地舒单抗单药组11例，BP预治疗组11例）治疗4个月后的此类结果。在BP预处理组中，骨代谢受到BP给药的抑制。在整个研究期间，两组的骨吸收标志物血清抗酒石酸酸性磷酸酶5 b和尿I型胶原交联N-端肽均较基线值显著降低。仅地舒单抗单药组的骨形成标志物骨碱性磷酸酶在4个月时显著降低，地舒单抗单药组的1型前胶原N-末端前肽在2个月和4个月时显著降低，而BP预处理组无显著变化。在地舒单抗单独给药组中，1，25（OH）2D 3和PTH在1周时显著升高，此后逐渐降低，但在BP预处理组中这些变化不显著。我们的结果表明，地舒单抗治疗对骨吸收标志物产生强烈抑制作用，对骨形成标志物产生轻度抑制作用。地舒单抗使1，25（OH）2D 3和PTH显著升高，但BP预处理组中未发生变化。当前对照试验NCT 02156960。2014年5月31日注册。
Denosumab is a fully human monoclonal antibody that inhibits receptor activator of nuclear factor kappa-β ligand (RANKL). Previous reports have shown that denosumab treatment of osteoporotic patients decreases bone resorption and fracture risk, but there have been no clinical studies on changes in bone turnover markers, 1,25(OH)2D3, or parathyroid hormone (PTH) in denosumab therapy with or without bisphosphonate (BP) pre-treatment in Japan. Here, we report such findings in 22 patients (11 in the denosumab alone group and 11 in the BP pre-treated group) with osteoporosis following 4 months of treatment. Bone metabolism had been inhibited by prior BP administration in the BP pre-treated group. The bone resorption markers serum tartrate-resistant acid phosphatase type 5b and urinary type I collagen cross-linked N-telopeptide were significantly decreased from baseline values for the entire study period in both groups. The bone formation marker bone alkaline phosphatase was significantly decreased at 4 months in the denosumab alone group only, and N-terminal propeptide of type 1 procollagen was significantly decreased at 2 and 4 months in the denosumab alone group versus no remarkable change in the BP pre-treated group. In the denosumab alone group, 1,25(OH)2D3 and PTH were significantly increased at 1 week and decreased gradually thereafter, but these did not change notably in the BP pre-treated group. Our results suggest that treatment with denosumab causes a strong inhibitory effect on bone resorption markers and mild inhibitory effect on bone formation markers. 1,25(OH)2D3 and PTH were significantly increased by denosumab but these did not change in the BP pre-treated group. Current Controlled Trials NCT02156960. Registered 31 May 2014.