To assess the safety and efficacy of low-dose intravenous (IV)
calcitriol therapy for the treatment of
secondary hyperparathyroidism, 21
hemodialysis patients with
amino-terminal parathyroid hormone (N-PTH) levels greater than 4 times normal were treated for 12 to 24 months in a prospective trial. The initial dose was 0.50 microgram, which was titrated every 3 months thereafter, as dictated by predialysis
calcium,
phosphorus, and N-PTH concentration.
Dialysate calcium concentration was 1.5 mmol/L. Low-dose IV
calcitriol decreased the N-PTH concentration to 48 +/- 6% and 29 +/- 5% of baseline following 12 and 24 months of
therapy, respectively. The maximum dose of
calcitriol was 0.92 +/- 0.11 microgram (0.50 to 2.25 micrograms). After 12 months of
therapy, serum
calcium increased from 2.22 +/- 0.04 to 2.41 +/- 0.03 mmol/L (8.9 +/- 0.2 to 9.7 +/- 0.1 mg/dL) without change thereafter. Baseline serum
phosphorus was 1.44 +/- 0.09 mmol/L (4.5 +/- 0.3 mg/dL), and was unaltered by
calcitriol therapy. Control of serum
phosphorus was achieved with
calcium-containing
phosphate binders, except in three patients who were subsequently withdrawn from the study after 12 months because of persistent
hyperphosphatemia due to noncompliance. We conclude that long-term, low-dose IV
calcitriol is a safe and effective
therapy for most
hemodialysis patients with
secondary hyperparathyroidism. In contrast to conventional dosing regimens, low-dose IV
therapy does not necessitate the use of
aluminum-containing
phosphate binders and/or a low-
calcium dialysate bath.