A randomised clinical study of alfacalcidol and paricalcitol
Abstract
Vitamin D analogs are used for treatment of secondary hyperparathyroidism in patients with chronic kidney disease in order to prevent renal osteodystrophy, bone fracture and pain. Calcium and phosphate levels increase with increasing doses of vitamin D analogs and are associated with increased risk of vascular calcification and cardiovascular morbidity and mortality. Therefore, in everyday clinical practice, hypercalcemia and hyperphosphatemia often limits the ability to suppress secondary hyperparathyroidism in patients with chronic kidney disease. In Denmark, alfacalcidol and paricalcitol are the most frequently used vitamin D analogs. The present thesis describes the first comparative study of alfacalcidol and paricalcitol and their ability to control the disturbances in the mineral metabolism in hemodialysis patients. In a multicenter randomised 2 × 16-week cross-over study (n = 86), with a 6-week wash out period preceding and between treatment periods, intravenous alfacalcidol and paricalcitol were given by forced titration (50% dose increase) every second week, until parathyroid hormone were sufficiently suppressed or ionised calcium and/or phosphate levels were elevated. Due to the presence of a period effect, only data from the initial 16-week intervention period (n = 80) were available for statistical tests of effect on parathyroid hormone. The proportion of patients achieving a 30% decrease in parathyroid hormone over the last four weeks was similar in the two…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 86 participants or records.
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