Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial.

Autor: Pérez-Castrillón JL; Department of Internal Medicine, Hospital Universitario Río Hortega, Valladolid, Spain.; School of Medicine, Universidad de Valladolid, Valladolid, Spain., Dueñas-Laita A; School of Medicine, Universidad de Valladolid, Valladolid, Spain.; Clinical Toxicology Unit, Hospital Universitario Río Hortega, Valladolid, Spain., Gómez-Alonso C; Bone Metabolism Unit, Hospital Universitario Central de Asturias - ISPA, Oviedo, Spain., Jódar E; Department of Endocrinology & Clinical Nutrition, Hospital Universitario Quironsalud Madrid, Madrid, Spain.; School of Health Sciences, Universidad Europea, Madrid, Spain., Del Pino-Montes J; School of Medicine, Universidad de Salamanca, Salamanca, Spain.; Department of Rheumatology, Hospital Universitario de Salamanca, Salamanca, Spain., Brandi ML; FIRMO Foundation (Fondazione Italiana Ricerca sulle Malattie dell'Osso), Florence, Italy., Cereto Castro F; Department of Internal Medicine, Hospital Quirón Barcelona, Barcelona, Spain., Quesada-Gómez JM; Physiopathology of Endocrine Vitamin D System Biotechnology and Aging, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.; Endocrinology and Nutrition Unit, Hospital Universitario Reina Sofía, Córdoba, Spain., Gallego López L; Department of Internal Medicine, Hospital Universitario Virgen Macarena, Seville, Spain., Olmos Martínez JM; Internal Medicine Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.; School of Medicine, Universidad de Cantabria, Santander, Spain.; Infection and Immunity Area, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Santander, Spain., Alhambra Expósito MR; Physiopathology of Endocrine Vitamin D System Biotechnology and Aging, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.; Endocrinology and Nutrition Unit, Hospital Universitario Reina Sofía, Córdoba, Spain., Galarraga B; Department of Rheumatology, Hospital Quirónsalud Bizkaia, Erandio, Spain.; Department of Medicine, University of the Basque Country, Leioa, Spain., González-Macías J; School of Medicine, Universidad de Cantabria, Santander, Spain.; Infection and Immunity Area, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Santander, Spain., Neyro JL; Gynecology and Obstetrics Service, Hospital Universitario Cruces, Barakaldo, Spain.; International Master on Climacteric and Menopause, Universidad de Madrid (UDIMA), Madrid, Spain., Bouillon R; Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium., Hernández-Herrero G; R&D and Innovation Department, Faes Farma, Leioa, Spain., Fernández-Hernando N; R&D and Innovation Department, Faes Farma, Leioa, Spain., Chinchilla SP; R&D and Innovation Department, Faes Farma, Leioa, Spain.
Jazyk: angličtina
Zdroj: Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research [J Bone Miner Res] 2023 Apr; Vol. 38 (4), pp. 471-479. Date of Electronic Publication: 2023 Feb 13.
DOI: 10.1002/jbmr.4776
Abstrakt: Vitamin D plays a major role in bone health and probably also in multiple extraskeletal acute and chronic diseases. Although supplementation with calcifediol, a vitamin D metabolite, has demonstrated efficacy and safety in short-term clinical trials, its effects after long-term monthly administration have been studied less extensively. This report describes the results of a 1-year, phase III-IV, double-blind, randomized, controlled, parallel, multicenter superiority clinical trial to assess the efficacy and safety of monthly calcifediol 0.266 mg versus cholecalciferol 25,000 IU (0.625 mg) in postmenopausal women with vitamin D deficiency (25(OH)D < 20 ng/mL). A total of 303 women were randomized and 298 evaluated. Patients were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months (Group A1), calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months (Group A2), and cholecalciferol 25,000 IU/month (0.625 mg/month) for 12 months (Group B). By month 4, stable 25(OH)D levels were documented with both calcifediol and cholecalciferol (intention-to-treat population): 26.8 ± 8.5 ng/mL (Group A1) and 23.1 ± 5.4 ng/mL (Group B). By month 12, 25(OH)D levels were 23.9 ± 8.0 ng/mL (Group A1) and 22.4 ± 5.5 ng/mL (Group B). When calcifediol treatment was withdrawn in Group A2, 25(OH)D levels decreased to baseline levels (28.5 ± 8.7 ng/mL at month 4 versus 14.4 ± 6.0 ng/mL at month 12). No relevant treatment-related safety issues were reported in any of the groups. The results confirm that long-term treatment with monthly calcifediol in vitamin D-deficient patients is effective and safe. The withdrawal of treatment leads to a pronounced decrease of 25(OH)D levels. Calcifediol presented a faster onset of action compared to monthly cholecalciferol. Long-term treatment produces stable and sustained 25(OH)D concentrations with no associated safety concerns. © 2023 Faes Farma SA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
(© 2023 Faes Farma SA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).)
Databáze: MEDLINE
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