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dc.contributor.author | Pérez Castrillon, José Luis | |
dc.date.accessioned | 2024-01-17T19:21:59Z | |
dc.date.available | 2024-01-17T19:21:59Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Journal of Bone and Mineral Research, Vol. 38, No. 4, Abril 2023, pp 471–479. | es |
dc.identifier.issn | 0884-0431 | es |
dc.identifier.uri | https://uvadoc.uva.es/handle/10324/64704 | |
dc.description | Producción Científica | es |
dc.description.abstract | 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 month12, 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 When calcifediol treatment was withdrawn in Group A2, 25(OH)D levels decreased to baseline levels (28.5 8.7 ng/mL at month 4 versus 14.4 6.0 ng/mL at month 12).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. | es |
dc.format.mimetype | application/pdf | es |
dc.language.iso | eng | es |
dc.publisher | Wiley | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.subject | Endocrinologia y Metabolismo | es |
dc.subject.classification | CALCIFEDIOL; CHOLECALCIFEROL; VITAMIN D DEFICIENCY; MENOPAUSE | es |
dc.title | Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial | es |
dc.type | info:eu-repo/semantics/article | es |
dc.rights.holder | FAES | es |
dc.identifier.doi | DOI: 10.1002/jbmr.4776 | es |
dc.identifier.publicationfirstpage | 471 | es |
dc.identifier.publicationissue | 4 | es |
dc.identifier.publicationlastpage | 479 | es |
dc.identifier.publicationtitle | Journal of Bone and Mineral Research | es |
dc.identifier.publicationvolume | 38 | es |
dc.peerreviewed | SI | es |
dc.description.project | FAES | es |
dc.type.hasVersion | info:eu-repo/semantics/publishedVersion | es |