OP0296 SUPERIOR EFFICACY OF CALCIFEDIOL SOFT GELATIN CAPSULES VS CHOLECALCIFEROL FOR THE MANAGEMENT OF VITAMIN D DEFICIENCY IN POSTMENOPAUSAL WOMEN: A TREATMENT TO BE CONSIDERED IN THERAPEUTIC GUIDELINES

Abstract

Background: Vitamin D deficiency is a highly prevalent entity worldwide, with relevance in specific diseases and stages of life1. Few guidelines assess the indications and optimal dosing in the general population, and although there is no international consensus, 800IU/day is associated with benefits in bone metabolism. Calcifediol, a vitamin D analog, is presented as a therapeutic alternative. Objectives: To assess the efficacy of calcifediol in the treatment of vitamin D deficiency, compared with therapeutic guidelines recommendations for cholecalciferol in postmenopausal women. Methods: Phase III-IV, double blind, randomised, controlled, multicentre superiority clinical trial. Postmenopausal women with baseline levels of 25(OH)D < 20 ng/mL were randomised to three arms: 266 mcg of calcifediol/month for 4 or 12 months (standard and test regime), or to cholecalciferol 25000 IU/month for 12 months (as per therapeutic guidelines). Results from an interim analysis - performed upon completion of month 4 visit by 100% of evaluable patients - are presented and reported without unblinding the study treatments. Both calcifediol groups are summarised for analysis. The trial has been approved by the corresponding ethics committees and national competent authorities. Results: 298 women were included in the ITT analysis. The average age was 63.4 ± 8.2 years, mean BMI was 29.3 ± 6 Kg/m2, 10.7% had osteoporosis and received treatment. All demographic characteristics and risk factors for osteoporosis were balanced amongst groups. When analysing per treatment group,13.5% and 35% of women in the calcifediol group reached values of 25(OH)D > 30ng/mL at 1 and 4 months when compared to 0% and 8.2% respectively in the cholecalciferol group (p<0.01), achieving target levels in a rapid manner ([Figure 1][1]). ![Figure 1.][2] Figure 1. Regarding baseline levels, 25% of the population had levels <10ng/mL; in this group there were no statistically significant differences between both treatments, possibly due to the limited sample size. In the group with baseline levels from 10 to<20 ng/mL, a statistically significant mean difference was observed at months 1 and 4, with a greater proportion of patients achieving both therapeutic levels in the calcifediol group (Table 1). No relevant safety issues were reported for the present analysis. View this table: Table 1. Conclusion: Calcifediol shows a greater efficacy than cholecalciferol regime (as recommended in therapeutic guidelines), for the treatment of vitamin D deficiency in postmenopausal women and in a timely manner, which could impact osteoporosis treatment. Cholecalciferol fails to achieve recommended levels in a significant proportion of this population. Baseline vitamin D levels are to be considered for the supplementation of vitamin D. References: [1]Amrein, K., Scherkl, M., Hoffmann, M. et al. Vitamin D deficiency 2.0: an update on the current status worldwide. Eur J Clin Nutr (2020). Acknowledgments: Osteoferol Study Group principal investigators and their teams: F Cereto, ML Brandi, E Jodar, JM Quesada-Gómez, JM Olmos-Martínez, MA Colmenero-Camacho, R Alhambra, C Gómez-Alonso, B Galarraga Disclosure of Interests: Javier del Pino Grant/research support from: Roche, Bristol, Consultant of: Gedeon, José Luis Pérez-Castrillón Grant/research support from: Farmalider, Pfizer, Consultant of: Farmalider, Faes Farma, Gedeon-Richter, Speakers bureau: Amgen, Lilly, MSD, Faes Farma, Antonio Dueñas-Laita Grant/research support from: Faes Farma, Farmalider, Consultant of: Faes Farma, Speakers bureau: Farmalider, Gonzalo Hernandez Employee of: Faes Farma S.A., Paula Arranz-Gutiérrez Employee of: Faes Farma, Sandra Pamela Chinchilla Employee of: Faes Farma S.A. [1]: #T1 [2]: pending:yes