Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease. Reduced synthesis of active vitamin D contributes to secondary hyperparathyroidism. Therefore we primarily manage this condition with activated vitamin D (alfacalcidol). However hypercalcemia and hyperphosphatemia may limit the use of alfacalcidol. MedDRA version: 8.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Trade Name: Zemplar
Pharmaceutical Form: Solution for injection
Trade Name: Etalpha
Pharmaceutical Form: Solution for injection
Sponsors
Roskilde Amts Sygehus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Age >18 years b. Sekundary hyperparathyreoidism (iPTH > 350 pg/ml )without treatment or after a break of vitamin D treatment of min. 6 weeks. c. Chronic uremia in hæmodialysis. d. P-fosfat =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Diagnosed malign disease. b. Diseases or conditions making the patient unable to participate. c. Expected survival less than one year. d. Pregnancy and nursing. e. Allergic to contents in the medications. f. In treatment with calcimimetics g. Participating in other intervention studies wich can affect endpoints of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • investigating the effect of alfacalcidol and paricalcitol on secondary hyperparathyreoidim, estimated by iPTH in hemodialysis patients. • investigating whether there is a difference between how many patients who reach a 30% or more reduction in iPTH during treatment with alfacalcidol or paricalcitol. ;Main Objective: The primary objective of this study is to evaluate the effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia.;Secondary Objective: basisk fosfatase, 25OH-vitamin D, 1,25 OH2-vitamin D ioniseret calcium x fosfat product, blood pressure, pulse, pulspressure, parathyroidektomi, use of calcimimetics will also be registrered during the study. | — |
Countries
Denmark
Outcome results
None listed