An assessment of cinacalcet HCI effects on bone histology in dialysis patients with secondary hyperparathyroidism

H. H. Malluche, M. C. Monier-Faugere, G. Wang, J. M. Frazão, C. Charytan, J. W. Coburn, D. W. Coyne, M. R. Kaplan, N. Baker, L. C. McCary, S. A. Turner, W. G. Goodman

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101 Scopus citations

Abstract

Aims: Cinacalcet lowers plasma parathyroid harmone (PTH) levels in patients with secondary hyperparathyroidism (sHPT), but the bone histologic response has not been described. This prospective, double-blind, placebo-controlled trial assessed the effects of cinacalcet on bone histology and serum markers of bone metabolism in dialysis patients with sHPT. Methods: Patients with intact PTH (iPTH) ≥ 300 pg/ml were randon-dy assigned 2:1 to receive cinacalcet or placebo with concurrent vitamin D and/or phosphate binder therapy. Cinacalcet (30-180 mg/day) was used to achieve iPTH levels ≤200 pg/ml. Bone biopsies were performed before and after one year of treatment. Results: Baseline and end-of-study data were available from 32 patients (19 cinacalcet, 13 placebo). Baseline bone turnover was elevated in 27, reduced in 3 and normal in 2 patients. Serum bone-specific alkaline phosphatase (BSAP) and N-telopeptide (NTx) were elevated. Cinacalcet treatment decreased PTH and diminished activation frequency, bone formation rate/bone surface, and fibrosis surface/bone surface. Adynamic bone was observed in three patients receiving cinacalcet; in two of these, PTH levels were persistently low (<100 pg/ml). The histomorphometric parameter changes in bone corresponded to PTH, BSAP and NTx reductions. Bone mineralization parameters remained normal. Conclusions. Treatment with cinacalcet lowered PTH and reduced bone turnover and tissue fibrosis among most dialysis patients with biochemical evidence of sHPT.

Original languageEnglish
Pages (from-to)269-277
Number of pages9
JournalClinical Nephrology
Volume69
Issue number4
DOIs
StatePublished - Apr 2008

Keywords

  • Cinacalcet
  • Randomized clinical trial
  • Renal osteodystrophy
  • Secondary hyperparathyroidism

ASJC Scopus subject areas

  • Nephrology

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