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Efficacy and Safety of Weekly Calcifediol Formulations (75 and 100 μg) in Subjects with Vitamin D Deficiency: A Phase II/III Randomised Trial

E. Jódar-Gimeno, JL. Pérez-Castrillón, J. Nociar, M. Lojka, D. Nikolov, F. Cereto-Castro, S. Novković, U. Tarantino, N. Mehsen-Cetre, P. Arranz, CM. Ostalé, A. García-Bea, I. Gilaberte

. 2024 ; 16 (22) : . [pub] 20241105

Jazyk angličtina Země Švýcarsko

Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze II, multicentrická studie, klinické zkoušky, fáze III

Perzistentní odkaz   https://www.medvik.cz/link/bmc25003514

Grantová podpora
HIDR-0320/DR Faes Farma (Spain)

BACKGROUND/OBJECTIVE: Optimal vitamin D levels are required for bone health and proper functionality of the nervous, musculoskeletal and immune systems. The objective of this study was to assess the efficacy and safety profiles of new weekly calcifediol formulations with the potential to improve adherence and outcome. METHODS: A Phase II-III, double-blind, randomized, multicentre trial (EudraCT 2020-001099-14 and NCT04735926). Subjects were randomized 2:2:1 to calcifediol 75 μg, 100 μg and placebo. 25(OH)D levels were measured at 4, 16, 24, 32 and 52 weeks. The main outcome was the percentage of subjects who achieved a response defined as 25(OH)D levels ≥20 ng/mL and/or ≥30 ng/mL at week 16. RESULTS: 398 subjects (51.1 ± 15.96 years, 74.2% females, 98.7% Caucasian) with plasma 25(OH)D levels between 10 and 20 ng/mL were randomized. A total of 376 subjects completed 16 weeks of treatment, and 355 subjects completed the study. Six patients withdrew due to an adverse event, all unrelated to treatment. At week 16, 93.6% and 74.4% of subjects receiving calcifediol 75 μg achieved response levels of ≥20 ng/mL and ≥30 ng/mL, respectively. The calcifediol 100 μg group showed 98.7% and 89.9% of responders for ≥20 ng/mL and ≥30 ng/mL, respectively. Both calcifediol groups showed superiority over placebo at each response level at all time points analyzed (p < 0.0001). Calcifediol treatments increased 25(OH)D levels from baseline to week 24 and remained stable thereafter. The frequency of treatment-emergent adverse events was balanced between groups. CONCLUSIONS: New weekly calcifediol 75 and 100 μg formulations showed an effective and sustained response with a good long-term safety profile.

Citace poskytuje Crossref.org

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