Comparison of the effects calcitriol and maxacalcitol on secondary hyperparathyroidism in patients on chronic haemodialysis: A randomized propective multicenter trial

Matsuhiko Hayashi, Yoshitsugu Tsuchiya, Yoshiaki Itaya, Tsuneo Takenaka, Kenji Kobayashi, Mamoru Yoshizawa, Ryuichi Nakamura, Toshiaki Monkawa, Atsuhiro Ichihara

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Abstract

Background. To identify differences between the effects of calcitriol and the calcitriol analogue, maxacalcitol, on parathyroid hormone (PTH) and bone metabolisms, we conducted a randomized prospective multicentre study on patients on chronic haemodialysis. Methods. We randomly assigned 91 patients with secondary hyperparathyroidism [intact PTH (iPTH) ≥150 pg/ml] to have either calcitriol (47 patients) or maxacalcitol (44 patients) therapy, for 12 months after a 1 month control period. Serum electrolytes, bone alkaline phosphatase (bAP), iPTH, total PTH and PTH(1-84) (whole PTH) levels were measured periodically. The first end point was a serum iPTH of <150 pg/ml, the second was the iPTH levels obtained. Results. Treatment was discontinued for various reasons in nine patients in each group, but no serious side effects were observed in either group. The numbers of cases reaching the first end point were not significantly different between the two groups. Serum calcium concentration was significantly higher in the maxacalcitol than the calcitriol group during early treatment, but not at the end of treatment. Throughout the treatment period there were no significant differences between the two groups in serum iPTH, inorganic phosphate, the product of the serum calcium and inorganic phosphorus concentrations, bAP, or the ratio of whole PTH to total PTH minus whole PTH. Nor were the changes in these parameters significantly different between the two groups comparing the patients with moderate to severe hyperparathyroidism (basal iPTH ≥500 pg/ml). Conclusion. Calcitriol and maxacalcitol are equally effective on PTH and bone metabolism.

Original languageEnglish
Pages (from-to)2067-2073
Number of pages7
JournalNephrology Dialysis Transplantation
Volume19
Issue number8
DOIs
Publication statusPublished - 2004 Aug

Fingerprint

Secondary Hyperparathyroidism
Calcitriol
Parathyroid Hormone
Multicenter Studies
Renal Dialysis
Bone and Bones
Serum
Alkaline Phosphatase
Calcium
Therapeutics
maxacalcitol
Hyperparathyroidism
Phosphorus
Electrolytes
Phosphates
Prospective Studies

Keywords

  • Bone alkaline-phosphatase
  • Calcitriol
  • End-stage renal failure
  • Maxacalcitol
  • Secondary hyperparathyroidism
  • Vitamin D analogue

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

Cite this

Comparison of the effects calcitriol and maxacalcitol on secondary hyperparathyroidism in patients on chronic haemodialysis : A randomized propective multicenter trial. / Hayashi, Matsuhiko; Tsuchiya, Yoshitsugu; Itaya, Yoshiaki; Takenaka, Tsuneo; Kobayashi, Kenji; Yoshizawa, Mamoru; Nakamura, Ryuichi; Monkawa, Toshiaki; Ichihara, Atsuhiro.

In: Nephrology Dialysis Transplantation, Vol. 19, No. 8, 08.2004, p. 2067-2073.

Research output: Contribution to journalArticle

Hayashi, Matsuhiko ; Tsuchiya, Yoshitsugu ; Itaya, Yoshiaki ; Takenaka, Tsuneo ; Kobayashi, Kenji ; Yoshizawa, Mamoru ; Nakamura, Ryuichi ; Monkawa, Toshiaki ; Ichihara, Atsuhiro. / Comparison of the effects calcitriol and maxacalcitol on secondary hyperparathyroidism in patients on chronic haemodialysis : A randomized propective multicenter trial. In: Nephrology Dialysis Transplantation. 2004 ; Vol. 19, No. 8. pp. 2067-2073.
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abstract = "Background. To identify differences between the effects of calcitriol and the calcitriol analogue, maxacalcitol, on parathyroid hormone (PTH) and bone metabolisms, we conducted a randomized prospective multicentre study on patients on chronic haemodialysis. Methods. We randomly assigned 91 patients with secondary hyperparathyroidism [intact PTH (iPTH) ≥150 pg/ml] to have either calcitriol (47 patients) or maxacalcitol (44 patients) therapy, for 12 months after a 1 month control period. Serum electrolytes, bone alkaline phosphatase (bAP), iPTH, total PTH and PTH(1-84) (whole PTH) levels were measured periodically. The first end point was a serum iPTH of <150 pg/ml, the second was the iPTH levels obtained. Results. Treatment was discontinued for various reasons in nine patients in each group, but no serious side effects were observed in either group. The numbers of cases reaching the first end point were not significantly different between the two groups. Serum calcium concentration was significantly higher in the maxacalcitol than the calcitriol group during early treatment, but not at the end of treatment. Throughout the treatment period there were no significant differences between the two groups in serum iPTH, inorganic phosphate, the product of the serum calcium and inorganic phosphorus concentrations, bAP, or the ratio of whole PTH to total PTH minus whole PTH. Nor were the changes in these parameters significantly different between the two groups comparing the patients with moderate to severe hyperparathyroidism (basal iPTH ≥500 pg/ml). Conclusion. Calcitriol and maxacalcitol are equally effective on PTH and bone metabolism.",
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T2 - A randomized propective multicenter trial

AU - Hayashi, Matsuhiko

AU - Tsuchiya, Yoshitsugu

AU - Itaya, Yoshiaki

AU - Takenaka, Tsuneo

AU - Kobayashi, Kenji

AU - Yoshizawa, Mamoru

AU - Nakamura, Ryuichi

AU - Monkawa, Toshiaki

AU - Ichihara, Atsuhiro

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N2 - Background. To identify differences between the effects of calcitriol and the calcitriol analogue, maxacalcitol, on parathyroid hormone (PTH) and bone metabolisms, we conducted a randomized prospective multicentre study on patients on chronic haemodialysis. Methods. We randomly assigned 91 patients with secondary hyperparathyroidism [intact PTH (iPTH) ≥150 pg/ml] to have either calcitriol (47 patients) or maxacalcitol (44 patients) therapy, for 12 months after a 1 month control period. Serum electrolytes, bone alkaline phosphatase (bAP), iPTH, total PTH and PTH(1-84) (whole PTH) levels were measured periodically. The first end point was a serum iPTH of <150 pg/ml, the second was the iPTH levels obtained. Results. Treatment was discontinued for various reasons in nine patients in each group, but no serious side effects were observed in either group. The numbers of cases reaching the first end point were not significantly different between the two groups. Serum calcium concentration was significantly higher in the maxacalcitol than the calcitriol group during early treatment, but not at the end of treatment. Throughout the treatment period there were no significant differences between the two groups in serum iPTH, inorganic phosphate, the product of the serum calcium and inorganic phosphorus concentrations, bAP, or the ratio of whole PTH to total PTH minus whole PTH. Nor were the changes in these parameters significantly different between the two groups comparing the patients with moderate to severe hyperparathyroidism (basal iPTH ≥500 pg/ml). Conclusion. Calcitriol and maxacalcitol are equally effective on PTH and bone metabolism.

AB - Background. To identify differences between the effects of calcitriol and the calcitriol analogue, maxacalcitol, on parathyroid hormone (PTH) and bone metabolisms, we conducted a randomized prospective multicentre study on patients on chronic haemodialysis. Methods. We randomly assigned 91 patients with secondary hyperparathyroidism [intact PTH (iPTH) ≥150 pg/ml] to have either calcitriol (47 patients) or maxacalcitol (44 patients) therapy, for 12 months after a 1 month control period. Serum electrolytes, bone alkaline phosphatase (bAP), iPTH, total PTH and PTH(1-84) (whole PTH) levels were measured periodically. The first end point was a serum iPTH of <150 pg/ml, the second was the iPTH levels obtained. Results. Treatment was discontinued for various reasons in nine patients in each group, but no serious side effects were observed in either group. The numbers of cases reaching the first end point were not significantly different between the two groups. Serum calcium concentration was significantly higher in the maxacalcitol than the calcitriol group during early treatment, but not at the end of treatment. Throughout the treatment period there were no significant differences between the two groups in serum iPTH, inorganic phosphate, the product of the serum calcium and inorganic phosphorus concentrations, bAP, or the ratio of whole PTH to total PTH minus whole PTH. Nor were the changes in these parameters significantly different between the two groups comparing the patients with moderate to severe hyperparathyroidism (basal iPTH ≥500 pg/ml). Conclusion. Calcitriol and maxacalcitol are equally effective on PTH and bone metabolism.

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KW - Vitamin D analogue

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