Calcitriol Versus Calcitriol and Low Dose Cinacalcet for Treating Severe Secondary Hyperparathyroidism in Hemodialysis Patients: A Randomized Clinical Trial

Secondary hyperparathyroidism is prevalent among hemodialysis patients associated with vascular and skeletal complications. Thus, treatment is required, specially before kidney transplantation.

This study aimed to compare the efficacy of calcitriol and cinacalcet versus standard-dose calcitriol in treating severe secondary hyperparathyroidism in hemodialysis patients.

This randomized clinical trial was conducted on 70 hemodialysis patients with severe secondary hyperparathyroidism who were randomly allocated to two intervention groups. Group A received calcitriol 1mg PO every other night, and group B took calcitriol 1mg PO every other night and cinacalcet 30mg PO daily. The improvement of laboratory parameters was investigated 3 and 6 months after the intervention.

There was no significant difference between the two groups regarding age, sex, body mass index, and duration of dialysis (P > 0.05). In group A, serum levels of calcium (P < 0.001) and parathyroid hormone (PTH) (P < 0.001) were significantly reduced comparedto baseline. However, phosphorus (P=0.175)andalbumin (P=0.143)serumlevelsshowednosignificant changes. In group B, calcium (P = 0.001), PTH (P < 0.001), and serum phosphorus (P < 0.001) levels were significantly decreased after the intervention. Nevertheless, serum albumin levels showed no significant changes from baseline (P = 0.061). Changes in serum phosphorus (P < 0.001) and PTH levels (P < 0.001) were significantly different between the groups. However, changes in serum calcium (P = 0.062) and albumin levels (P = 0.773) were not significantly different (Wilcoxon signed-rank test).

The results of this study showed that treatment with cinacalcet and calcitriol was more effective than calcitriol alone without any side effects.