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Endocrine Abstracts (2020) 70 OC2.6 | DOI: 10.1530/endoabs.70.OC2.6

Bone and Calcium

Superior efficacy of calcifediol soft gelatin capsules vs cholecalciferol independently of bmi, for the management of vitamin d deficiency in postmenopausal women: a treatment to be considered in therapeutic guidelines

Esteban Jódar1, José Luis Pérez-Castrillón2, Antonio Dueñas-Laita3, Gonzalo Hernández4, Nieves Fernández-Hernando4 & Paula Arranz-Gutiérrez4


1Hospital Universitario Quironsalud Madrid, Endocrinology and Nutrition Service, Pozuelo de Alarcón, Spain; 2Hospital Universitario Rio Hortega and Universidad de Valladolid, Internal Medicine Service, Valladolid, Spain; 3Hospital Universitario Rio Hortega and Universidad de Valladolid, Clinical Pharmacology Service, Valladolid, Spain; 4Faes Farma S.A., R$D+i Department, Leioa, Spain


Background: Vitamin D deficiency is a worldwide health issue that affects more than one billion people. Few guidelines assess optimal dosing of vitamin D in general population, and although there is no international consensus, the optimum dosing for vitamin D3 and mainly calcifediol is not known.

Objective(s): To assess the efficacy of calcifediol in the treatment of vitamin D deficiency, compared with therapeutic guidelines recommendations for cholecalciferol in postmenopausal women.

Material and Methods: Phase III–IV, double blind, randomized, controlled, multicentre superiority clinical trial approved by the corresponding Ethics Committees and Health Authorities. Postmenopausal women with baseline levels of 25(OH)D < 20 ng/ml were randomised to calcifediol 266 µg /month for 4 or 12 months (standard and test regime), or to cholecalciferol 25 000 IU/month (as per therapeutic guidelines) for 12 months. Results from an interim analysis - performed upon completion of month 4 visit by 100% of evaluable patients - are presented and reported without unblinding subjects’ study treatments. Both calcifediol groups are summarised for analysis.

Results: 298 women were included in the ITT analysis. All demographic characteristics were balanced amongst groups. Regarding analysis based on World Health Organization classification for BMI (kg/m2), 41.3% were obese, 32.6% were overweight, 25,2% were normal weight and 1% were underweight. Due to limited sample size, underweight group is not considered for analysis. When treatments are compared for BMI groups at Month 4, mean change versus baseline and % subjects achieving 25(OH)D > 30 ng/ml resulted statistically significant (Table 1). When analysing per treatment group,13.5% and 35% of women in the calcifediol group reached 25(OH)D > 30 ng/ml at 1 and 4 months when compared to 0% and 8.2% respectively in the cholecalciferol group (P < 0.001). No relevant safety issues reported for the present analysis.

Table 1
NORMALOVERWEIGHTOBESE
Calcifediol (n = 58)Cholecalciferol (n = 17)Calcifediol (n = 59)Cholecalciferol (n = 38)Calcifediol (n = 80)Cholecalciferol (n = 43)
Mean Change (ng/ml)16.6*12.615.6***9.813.4***8.9
% Subjects with 25(OH)D > 3051.7*17.633.9**7.925**4.7
*P < 0.05; **P < 0.01; ***P < 0.001.

Conclusions: Calcifediol shows a greater efficacy than cholecalciferol (as recommended in therapeutic guidelines), for the treatment of vitamin D deficiency in postmenopausal women independently of their BMI. A significant percentage of patients on cholecalciferol group failed to reach recommended levels.

Acknowledgements: Osteoferol Study Group principal investigators and their teams: F Cereto, ML Brandi, J del Pino-Montes, JM Quesada-Gómez, MA Colmenero-Camacho, JM Olmos-Martínez, R Alhambra, C Gómez-Alonso, B Galarraga.

Volume 70

22nd European Congress of Endocrinology

Online
05 Sep 2020 - 09 Sep 2020

European Society of Endocrinology 

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