TitleCalcifediol Superior to Cholecalciferol in Treating Vitamin D Deficiency in Postmenopausal Women
By Shazia Qureshi
VIRTUAL -- May 25, 2021 -- Calcifediol appears to be superior to cholecalciferol in increasing levels of 25-hydroxyvitamin D (25[OH]D) over 1 year of treatment in postmenopausal women with vitamin D deficiency, according to a study presented at the Virtual 23rd European Congress of Endocrinology (ECE).
The findings are from a phase 3 / 4 study (EudraCT 2017-004028-31) that took place between March 2018 and October 2020 at 10 medical centres in Spain and Italy.
Esteban Jódar, MD, Hospital Universitario Quirónsalud, and Universidad Europea, Madrid, Spain, and colleagues recruited 303 postmenopausal women whose serum levels of 25(OH)D at baseline were
Patients were randomised 1:1:1 in double-blinded fashion to receive calcifediol 0.266 mg once a month for 12 months, calcifediol 0.266 mg once a month for 4 months followed by placebo for 8 months, or 25,000 IU of cholecalciferol once a month for 12 months.
In the intention-to-treat analysis (n = 298 patients), results showed that the concentration of 25(OH)D in serum increased by a mean of 9.7 ± 6.7 ng/ml in both calcifediol groups combined after the first month of treatment, which was a significantly higher increase from baseline compared with cholecalciferol-treated patients, in whom the mean increase was 5.1 ± 3.5 ng/ml (P
For the primary endpoint of serum 25(OH)D levels >30 ng/ml after 4 months of treatment, the researchers found that this was reached in 4.3 times more patients in both calcifediol groups combined, compared with the group receiving cholecalciferol treatment (P
“Discontinuation of calcifediol supplementation lowers 25(OH)D levels back to baseline, suggesting that long-term treatment is safe and necessary,” said Dr. Jódar.
When comparing the calcifediol-only treatment versus cholecalciferol, increases in serum 25(OH)D remained stable in both groups over the study year, but calcifediol was superior over cholecalciferol over the whole year.
In addition, the per-protocol analysis, which included 170 patients, showed that mean 25(OH)D was significantly higher in the calcifediol-only group versus cholecalciferol after 1 month (P P P
The researchers noted that calcifediol is a biomarker of vitamin D status and is widely prescribed in Spain, but not elsewhere.
Funding for this study was provided by Faes Farma.
The ECE is sponsored by the European Society of Endocrinology.
[Presentation title: Efficacy and Safety of Long-Term Treatment With Monthly Calcifediol Soft Capsules in Vitamin D Deficient Patients. Abstract AEP83]