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临床试验/JPRN-UMIN000000475
JPRN-UMIN000000475已完成未知

Therapeutic strategy of relative hypoparathyroidism in hemodialysis patients using sevelamer hydrochloride, with special reference to vitamin D administration - The effect of sevelamer hydrochloride on relative hypoparathyroidism in hemodialysis patients

Hokusetsu ROD Study Group0 个研究点目标入组 40 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

Sevelamer hydrochloride has been expected to control hyperphosphatemia without calcium load. In this study, we investigated the effects of attenuation of calcium load by sevelamer hydrochloride on bone metabolic markers in 46 hemodialysis patients with serum intact parathyroid hormone (iPTH) levels < 150 pg/mL. After replacement of calcium carbonate with sevelamer, their serum calcium levels decreased. The iPTH levels increased after 4 weeks and the magnitude of the increase was significantly correlated with the extent of decrease in serum calcium concentration. The whole PTH, bone alkaline phosphatase (BAP), and bone-specific tartrate-resistant acid phosphatase (TRAP5b) levels were also increased after 12 weeks. However, the relationship between iPTH and BAP or TRAP5b which was observed before the sevelamer replacement therapy was preserved only in the patients with serum iPTH levels < 60 pg/mL at enrollment. Thus, in the patients with pretreatment iPTH levels >= 60 and < 150 pg/mL, the increase in iPTH level might not always result in the improvement of bone metabolism. In the patients administered with vitamin D at enrollment, the frequency of overshooting of iPTH, BAP, or TRAP5b was lower than that in the patients without vitamin D administration. In conclusion, replacing calcium carbonate with sevelamer could be a therapeutic option in the patients with hypoparathyroidism (iPTH < 60 pg/mL) to improve bone metabolism and vitamin D might be useful to avoid the excess enhancement of bone turnover by sevelamer therapy.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Hospitalized or medically unstable patients

研究者

发起方
Hokusetsu ROD Study Group

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