Behandling af sekundær hyperparathyreoidisme hos uræmiske patienter.En sammenlignenede undersøgelse mellem virkningen af alfacalcidol og paricalcitol.

Conditions: 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: 8.1Level: LLTClassification code 10020708Term: Hyperparathyroidism secondary

Registration Number: EUCTR2006-005981-37-DK

Lead Sponsor: Roskilde Amts Sygehus

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 1,8 mmol/l
e. P-calciumion < 1,25 mmol/l
f. Recieving maximal dose of calciumcontaining fosfatbinder.
g. Accepting 2 x 6 weeks without D-vitamin treatment.
h. Safe antikonception for women in fertile age and negativ pregnancy-test before inklusion.
i. Need of calcimimetics or parathyroidektomi is not expected during the following year.
j. Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.