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 Detalle_Publicacion

Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial

Abstract: Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean ± standard deviation change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in patients treated with calcifediol and cholecalciferol, respectively). No relevant treatment-related safety issues were reported in any of the groups studied. These results thus confirm that calcifediol is effective, faster, and more potent than cholecalciferol in raising serum 25(OH)D levels and is a valuable option for the treatment of vitamin D deficiency.

Otras publicaciones de la misma revista o congreso con autores/as de la Universidad de Cantabria

 Fuente: Journal of Bone and Mineral Research, 2021, 36(10), 1967-1978

Editorial: John Wiley & Sons

 Año de publicación: 2021

Nº de páginas: 12

Tipo de publicación: Artículo de Revista

 DOI: 10.1002/jbmr.4387

ISSN: 0884-0431,1523-4681

Url de la publicación: https://www.doi.org/10.1002/jbmr.4387

Autoría

PÉREZ-CASTRILLÓN, JOSÉ LUIS

DUEÑAS-LAITA, ANTONIO

BRANDI, MARIA LUISA

JÓDAR, ESTEBAN

DEL PINO-MONTES, JAVIER

QUESADA-GÓMEZ, JOSÉ MANUEL

CERETO CASTRO, FERNANDO

GÓMEZ-ALONSO, CARLOS

GALLEGO LÓPEZ, LAURA

ALHAMBRA EXPÓSITO, MARÍA ROSA

GALARRAGA, BERNAT

HERNÁNDEZ-HERRERO, GONZALO

FERNÁNDEZ-HERNANDO, NIEVES

ARRANZ-GUTIÉRREZ, PAULA

CHINCHILLA, SANDRA P