Document Detail

Alfacalcidol in the therapy of renal bone disease.
MedLine Citation:
PMID:  11770836     Owner:  NLM     Status:  MEDLINE    
Parathyroid hormone increases due to hypocalcemia even in the early phases of renal insufficiency. At the same time, hyperphosphatemia develops due to decreasing renal excretion which, in turn, intensifies secondary hyperparathyroidism. The cornerstones for prevention and therapy of renal osteopathy are, therefore, efficient lowering of phosphate levels and the early substitution of vitamin-D3 metabolites. In a post marketing surveillance (PMS) of almost 2,000 dialysis patients with renal osteopathy, the course of therapy with Alfacalcidol (Bondiol) was observed over a 6-month period. In 55.9% of cases, Alfacalcidol was administered at a daily dose of 0.25 microg. In 26.6% of patients, Alfacalcidol was administered every second day at a dose of 0.25-1 microg/d. In 16.1% of patients, Alfacalcidol was administered as pulse-therapy, mostly at a dose of 1-2 microg once or twice per week. To lower phosphate levels, 54.8% of patients received calcium compounds, 9.2% aluminium compounds, and 21.7% aluminium compounds in combination with calcium compounds. 14.3% of patients did not receive phosphate binding agents. Two thirds of patients had received active vitamin-D3-metabolites prior to commencing therapy with alfacalcidol, most frequently calcitrol. In 58.1%, the dialysis solution used had a calcium concentration of 1.5 mmol/l (44.8%) or lower; whereas in 41.9%, a higher calcium concentration was used--mostly 1.75 mmol/l (3 8%). During the observation period, serum concentrations of calcium and phosphate remained constant, suggesting that the risk of hypercalcemia due to therapy with Alfacalcidol was not increased. It was found that elevated alkaline phosphatase and parathyroid hormone levels could be significantly lowered (statistically). These effects could be observed both in patients who had been previously treated with vitamin-D3-metabolites and in patients without prior therapy. Efficacy and tolerability of therapy with Alfacalcidol was assessed to be very high by the attending nephrologists.
M Ritzerfeld; M Klasser; H Mann
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  39     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2001 Dec 
Date Detail:
Created Date:  2001-12-27     Completed Date:  2002-05-22     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  546-50     Citation Subset:  IM    
Dialysezentrum, Aachen, Germany.
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MeSH Terms
Aged, 80 and over
Alkaline Phosphatase / metabolism
Aluminum Compounds / administration & dosage
Calcium / administration & dosage,  blood
Cholecalciferol / metabolism
Hydroxycholecalciferols / administration & dosage,  therapeutic use*
Middle Aged
Parathyroid Hormone / metabolism
Phosphates / administration & dosage,  blood
Product Surveillance, Postmarketing
Renal Dialysis
Renal Osteodystrophy / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Aluminum Compounds; 0/Hydroxycholecalciferols; 0/Parathyroid Hormone; 0/Phosphates; 67-97-0/Cholecalciferol; 7440-70-2/Calcium; EC Phosphatase; URQ2517572/alfacalcidol

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