Alfacalcidol vs Calcitriol in the Management of Patient With Hypoparathyroidism: A Randomized Controlled Trial

Context: Alfacalcidol and calcitriol are commonly used for managing hypoparathyroidism. Their relative merits have not been systematically assessed. Objective: We compared the effect of alfacalcidol and calcitriol on phosphatemic control, hypercalciuria, and associated factors in idiopathic-hypoparathyroidism (IH). Design and Setting: Open-label randomized controlled trial, tertiary care center. Subjects and Methods: IH patients with optimal calcemic control on alfacalcidol were continued on the same (n=20) or switched to calcitriol (n=25) at half of the ongoing alfacalcidol dose. The dose was adjusted during follow-up to maintain serum total calcium between 8.0 and 9.5 mg/dL. Serum calcium, phosphorus, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, 24-h urine calcium-to-creatinine ratio, and fractional excretion of phosphorus (FEPh) were measured at baseline and 6 months. Plasma intact-FGF23 was measured at final follow-up. Result: Patients receiving alfacalcidol and calcitriol had comparable serum calcium at 6 months (8.70.4 vs 8.9 +/- 0.4 mg/dL, P=0.13). Their median [interquartile range (IQR)] dose at 6 months was 2.0 (1.0-2.5) and 0.75 (0.5-1.0) mu g/d, respectively. Serum 1,25(OH)(2)D levels were physiological in both (35.3 +/- 11.6 and 32.3 +/- 16.9 pg/mL). Serum phosphate and calcium excretion were comparable in 2 arms. A majority had hyperphosphatemia (75% vs 76%), hypercalciuria (75% vs 72%), and elevated FGF23 (116 +/- 68 and 113 +/- 57 pg/mL). Age showed significant independent association with plasma FGF23 (beta = 1.9, P = 0.001). Average FEPh was low despite high FGF23. Conclusion: At optimal calcium control, both alfacalcidol and calcitriol lead to comparable but high serum phosphate levels, hypercalciuria, physiological circulating 1,25(OH)(2)D, and elevated FGF23. Further studies are required to systematically investigate other treatment options.