Dörr Katharina, Hödlmoser Sebastian, Kammer Michael, Reindl-Schwaighofer Roman, Lorenz Matthias, Reiskopf Bianca, Jagoditsch Rahel, Marculescu Rodrig, Oberbauer Rainer
Department of Nephrology, Medical University of Vienna, Vienna, Austria.
Section for Clinical Biometrics, Center for Medical Statistics, Informatics and Intelligent Systems (CeMSIIS), Medical University of Vienna, Vienna, Austria.
Front Med (Lausanne). 2022 Jul 6;9:948177. doi: 10.3389/fmed.2022.948177. eCollection 2022.
Secondary hyperparathyroidism in chronic kidney disease poses a major risk factor for vascular calcification and high bone turnover, leading to mineralization defects. The aim was to analyze the effect of active vitamin D and calcimimetic treatment on fibroblast growth factor 23 (FGF23), serum calcification propensity (T50), a surrogate marker of calcification stress and bone specific alkaline phosphatase (BAP) in hemodialysis. This is a subanalysis of a randomized trial comparing etelcalcetide vs. alfacalcidol in 62 hemodialysis patients for 1 year. We compared the change of BAP and serum calcification propensity between the two medications and assessed the influence of FGF23 change over time. We found no significant differences in the change of BAP or serum calcification propensity (T50) levels from baseline to study end between treatment arms (difference in change of marker between treatment with etelcalcetide vs. alfacalcidol: BAP : 2.0 ng/ml [95% CI-1.5,5.4], = 0.3; T50: -15 min [95% CI -49,19], = 0.4). Using FGF23 change over time, we could show that BAP levels at study end were associated with FGF23 change (-0.14 [95% CI -0.21, -0.08], < 0.001). We did not observe the same association between FGF23 change and T50 (effect of FGF23 change on T50: 3.7 [95% CI -5.1, 12], = 0.4; = 0.07 vs. = 0.06). No significant difference was found in serum calcification propensity (T50) values between treatment arms. FGF23 was not associated with serum calcification propensity (T50), but was negatively correlated with BAP underlying its role in the bone metabolism.
[www.ClinicalTrials.gov], identifier [NCT03182699].
慢性肾脏病中的继发性甲状旁腺功能亢进是血管钙化和高骨转换的主要危险因素，会导致矿化缺陷。目的是分析活性维生素D和拟钙剂治疗对血液透析患者成纤维细胞生长因子23（FGF23）、血清钙化倾向（T50，钙化应激的替代标志物）和骨特异性碱性磷酸酶（BAP）的影响。这是一项随机试验的亚分析，该试验比较了依特卡肽与阿法骨化醇对62例血液透析患者进行为期1年的治疗效果。我们比较了两种药物之间BAP和血清钙化倾向的变化，并评估了FGF23随时间变化的影响。我们发现，从基线到研究结束，各治疗组之间BAP或血清钙化倾向（T50）水平的变化无显著差异（依特卡肽与阿法骨化醇治疗之间标志物变化的差异：BAP：2.0 ng/ml [95% CI -1.5, 5.4] = 0.3；T50：-15分钟 [95% CI -49, 19] = 0.4）。利用FGF23随时间的变化，我们可以表明研究结束时BAP水平与FGF23变化相关（-0.14 [95% CI -0.21, -0.08]，P < 0.001）。我们未观察到FGF23变化与T50之间存在相同的关联（FGF23变化对T50的影响：3.7 [95% CI -5.1, 12] = 0.4；P = 0.07 vs. P = 0.06）。各治疗组之间血清钙化倾向（T50）值无显著差异。FGF23与血清钙化倾向（T50）无关，但与BAP呈负相关，表明其在骨代谢中的作用。
[www.ClinicalTrials.gov]，标识符 [NCT03182699]。
