Research to (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism

An inadequate treatment of secondary hyperparathyroidism can have severe consequences, such as hyperplastic parathyroid glands, renal osteodystrophy and cardiovascular diseases.

Paricalcitol (Zemplar®) is a recently introduced third generation vitamin D analogon.

Paricalcitol is supposed to have several advantages in comparison to the “old” vitamin D alfa-calcidol (Etalpha®).
According to several trials, paricalcitol corrects parathormone (PTH) levels faster and reduces the incidences of hypercalcemia. Trials and evidence are limited, so the question if parical-citol is more effective than the “old” vitamin D analoga alfacalcidol and calcitriol remains relevant. This trial compares paricalcitol with alfacalcidol, the most frequently used vitamin D in the Netherlands. Treatment with paricalcitol is four times more expensive that treatment with alfacalcidol. This trial compares effectiveness, safety and costs of paricalcitol and alfa-calcidol. With this trial treatment of secondary hyperparathyroidism in hemodialysis patients can be optimized.

Paricalcitol induces a more effective reduction of the PTH level than alfacalcidol in hemodialysis pa-tients with secondary hyperparathyroidism

NL
Paricalcitol geeft een effectievere daling van de PTH spiegel ten opzichte van alfacalcidol bij hemodi-alysepatiënten met secundaire hyperparathyreoïdie.

- PTH:

Baseline, every 4 weeks

- Ca 2+ tot:
Baseline, every 2 weeks

- Ca2+ ion:
Baseline, every 2 weeks

- Albumin:
Baseline, every 2 weeks

- P:
Baseline, every 2 weeks

- Ca x P:
Baseline, every 2 weeks

- Bone-AP:
Baseline, month 6, month 12

- Hb:
Every 4 weeks

- Ferritine:
Every 4 weeks

- Urea (BUN):
Baseline, month 6, month 12

- Creat:
Baseline, month 6, month 12

- CRP:
Baseline, month 6, month 12

Hemodialysis patients will be randomized.
Group A gets treated with alfacalcidol and Group B with paricalcitol.
After six months the groups switch.