title: No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial.
abstract: Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range.
authors.affiliation: Section of Nephrology, Department of Medicine, Roskilde Hospital, Roskilde, Denmark. dittehansen@dadlnet.dk
authors.forename: Ditte
authors.initials: D
authors.lastname: Hansen
authors.forename: Knud
authors.initials: K
authors.lastname: Rasmussen
authors.forename: Henning
authors.initials: H
authors.lastname: Danielsen
authors.forename: Helmut
authors.initials: H
authors.lastname: Meyer-Hofmann
authors.forename: Egidijus
authors.initials: E
authors.lastname: Bacevicius
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Lauridsen
authors.forename: Jens K
authors.initials: JK
authors.lastname: Madsen
authors.forename: Birgitte G
authors.initials: BG
authors.lastname: Tougaard
authors.forename: Peter
authors.initials: P
authors.lastname: Marckmann
authors.forename: Peter
authors.initials: P
authors.lastname: Thye-Roenn
authors.forename: Jørgen E
authors.initials: JE
authors.lastname: Nielsen
authors.forename: Svend
authors.initials: S
authors.lastname: Kreiner
authors.forename: Lisbet
authors.initials: L
authors.lastname: Brandi
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000097:blood; D018592:Cross-Over Studies; D004872:Ergocalciferols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006887:Hydroxycholecalciferols / Q000009:adverse effects / Q000627:therapeutic use*; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis / Q000009:adverse effects*
chemical_list: D004872:Ergocalciferols; D006887:Hydroxycholecalciferols; D010281:Parathyroid Hormone; D010758:Phosphorus; C084656:paricalcitol; D002118:Calcium; C008088:alfacalcidol