Long-term cinacalcet HCl treatment improved bone metabolism in Japanese hemodialysis patients with secondary hyperparathyroidism.

Abstract

BACKGROUND/AIMS:

Few clinical trials conducted with cinacalcet have thoroughly addressed its effects of on bone metabolism. We assessed the effects of cinacalcet on bone markers in Japanese hemodialysis (HD) patients with secondary hyperparathyroidism (SHPT).

METHODS:

200 Japanese HD patients with intact PTH (iPTH) levels > or = 300 pg/ml were enrolled. The dose of cinacalcet was titrated from 25 up to 100 mg/day to achieve iPTH levels < or = 250 pg/ml for 52 weeks.

RESULTS:

At the end of the study visit, 57.8% of patients (115/199) had achieved iPTH levels < or = 250 pg/ml. Serum Ca, phosphorus (P) and Ca x P levels decreased rapidly and were maintained throughout the study. At week 52, all bone metabolic markers levels had decreased significantly from baseline. Although bone resorption markers gradually decreased throughout the study period, bone alkaline phosphatase significantly increased during the first 4 weeks and then gradually decreased.

CONCLUSIONS:

The time courses of changes in bone markers after cinacalcet treatment resembled those observed after surgical parathyroidectomy (PTx), sometimes described as the hungry bone syndrome, indicating that cinacalcet treatment induces a rapid recovery in bone response to calcium. In addition, long-term efficacy and safety of cinacalcet were also observed in Japanese patients undertaking long-term hemodialysis (167.0 +/- 81.4 months).

• Authors: Takashi Shigematsu, Tadao Akizawa, Eiji Uchida, Yusuke Tsukamoto, Manabu Iwasaki, Shouzo Koshikawa, KRN1493 Study Group
• Journal: American journal of nephrology (Am J Nephrol) Vol. 29 Issue 3 Pg. 230-6 ( 2009) ISSN: 1421-9670 [Electronic] Switzerland
• PMID: 18797166 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: 2008 S. Karger AG, Basel.

Chemical References

• Naphthalenes
• Cinacalcet

Topics

• Adult
• Aged
• Bone Resorption (drug therapy)
• Bone and Bones (metabolism)
• Cinacalcet
• Female
• Humans
• Hyperparathyroidism, Secondary (drug therapy, etiology)
• Kidney Failure, Chronic (complications, metabolism, therapy)
• Male
• Middle Aged
• Naphthalenes (administration & dosage, therapeutic use)
• Renal Dialysis
• Treatment Outcome