No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: A randomized crossover trial

Ditte Hansen; Knud Rasmussen; Henning Danielsen; Helmut Meyer-Hofmann; Egidijus Bacevicius; Thomas G. Lauridsen; Jens K. Madsen; Birgitte G. Tougaard; Peter Marckmann; Peter Thye-Roenn; Jørgen E. Nielsen; Svend Kreiner; Lisbet Brandi

doi:10.1038/ki.2011.226

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: A randomized crossover trial

Ditte Hansen^*
, Knud Rasmussen
, Henning Danielsen
, Helmut Meyer-Hofmann
, Egidijus Bacevicius
, Thomas G. Lauridsen
, Jens K. Madsen
, Birgitte G. Tougaard
, Peter Marckmann
, Peter Thye-Roenn
, Jørgen E. Nielsen
, Svend Kreiner
, Lisbet Brandi

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

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.

Original language	English
Pages (from-to)	841-850
Number of pages	10
Journal	Kidney International
Volume	80
Issue number	8
DOIs	https://doi.org/10.1038/ki.2011.226
Publication status	Published - 2 Oct 2011

Funding

We are grateful to Eastern Danish Research Forum for Health Sciences for statistical assistance during study planning, and GCP unit at Copenhagen, Odense, and Aarhus University Hospital, for guidance concerning ICH guideline for Good Clinical Practice and data monitoring. We thank Niels Erik Frandsen, MD, Niels Jørgen Løkkegaard, MD, Jeppe Hagstrup Christensen, DMSc, Jesper Bech, PhD, Erling Bjerregaard Pedersen, DMSc, Hanne Agerskov, Sasikala Thineshkumar, MD, Kirsten Karstoft, Kirsten Holdensen, Charlotte Mose Skov, Vinie Meldgaard, Annelise Kjær for data collection, and Ove Østergaard, MD for acquisition of funding. This work was funded by Danish Kidney Association, Danish Society of Nephrology, Region Zealand Health Sciences Research Foundation, and Abbott Laboratories A/S. The funding sources have no influence on study design in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.

Keywords

activated vitamin D
hemodialysis
hyperparathyroidism
mineral metabolism

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10.1038/ki.2011.226

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Hansen, D., Rasmussen, K., Danielsen, H., Meyer-Hofmann, H., Bacevicius, E., Lauridsen, T. G., Madsen, J. K., Tougaard, B. G., Marckmann, P., Thye-Roenn, P., Nielsen, J. E., Kreiner, S., & Brandi, L. (2011). No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: A randomized crossover trial. Kidney International, 80(8), 841-850. https://doi.org/10.1038/ki.2011.226

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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.",

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author = "Ditte Hansen and Knud Rasmussen and Henning Danielsen and Helmut Meyer-Hofmann and Egidijus Bacevicius and Lauridsen, \{Thomas G.\} and Madsen, \{Jens K.\} and Tougaard, \{Birgitte G.\} and Peter Marckmann and Peter Thye-Roenn and Nielsen, \{J{\o}rgen E.\} and Svend Kreiner and Lisbet Brandi",

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Hansen, D, Rasmussen, K, Danielsen, H, Meyer-Hofmann, H, Bacevicius, E, Lauridsen, TG, Madsen, JK, Tougaard, BG, Marckmann, P, Thye-Roenn, P, Nielsen, JE, Kreiner, S & Brandi, L 2011, 'No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: A randomized crossover trial', Kidney International, vol. 80, no. 8, pp. 841-850. https://doi.org/10.1038/ki.2011.226

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AU - Hansen, Ditte

AU - Rasmussen, Knud

AU - Danielsen, Henning

AU - Meyer-Hofmann, Helmut

AU - Bacevicius, Egidijus

AU - Lauridsen, Thomas G.

AU - Madsen, Jens K.

AU - Tougaard, Birgitte G.

AU - Marckmann, Peter

AU - Thye-Roenn, Peter

AU - Nielsen, Jørgen E.

AU - Kreiner, Svend

AU - Brandi, Lisbet

PY - 2011/10/2

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N2 - 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.

AB - 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.

KW - activated vitamin D

KW - hemodialysis

KW - hyperparathyroidism

KW - mineral metabolism

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U2 - 10.1038/ki.2011.226

DO - 10.1038/ki.2011.226

M3 - Article

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AN - SCOPUS:80053562092

SN - 0085-2538

VL - 80

SP - 841

EP - 850

JO - Kidney International

JF - Kidney International

IS - 8

ER -

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: A randomized crossover trial

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