Calcifediol mensual frente a calcifediol quincenal en el tratamiento de pacientes osteoporóticos. Estudio en la vida real

Abstract

Objectives: To assess serum concentrations of 25-hydroxyvitamin D, 25(OH)D, in osteoporotic patients treated for one year with calcifediol. Methods: We have studied 156 patients with osteoporosis (23 males and 133 females), aged 71,9±9,6 years who had received treatment with calcifediol for at least one year. Ninety-two of them received 0.266 mg of calcifediol every fifteen days and the remaining 64 the same dose once a month. Serum levels of 25(OH)D, intact PTH (iPTH), procollagen type 1 amino-terminal propeptide (PINP) and C-terminal crosslinked telopeptide of type I collagen (CTX) were determined before and one year after starting treatment. Results: A significant increase in the concentration of 25(OH)D was observed with both treatment regimens (p<0.001). The percentage of patients who reached levels of 25(OH)D higher than 20 and 30 ng/ml was similar with both guidelines, while the percentage of patients exceeding 60 ng/ml was higher with the biweekly dose (p<0.01). The concentration of iPTH decreased significantly after the administration of calcifediol, although on this occasion there were no differences between the two forms of treatment. Both bone remodeling markers, PINP and CTX, decreased similarly in patients treated with antiresorptives (p<0.0001), without these changes being related to the calcifediol regimen. Conclusions: The monthly administration of 0.266 mg of calcifediol is adequate to achieve effective levels of vitamin D, and it is also safe enough to avoid reaching potentially harmful levels of it, so it would be preferable to the biweekly schedule in the usual clinical practice.

Efficacy and Safety of Calcifediol in Young Adults with Vitamin D Deficiency: A Phase I, Multicentre, Clinical Trial—POSCAL Study

“…These results are consistent with those from previous studies that used the same dosage of calcifediol in other populations. A previous retrospective observational study, conducted by Olmos et al (2018), included 156 patients with osteoporosis (23 males and 133 females) who had received monthly or biweekly treatments with calcifediol (0.266 mg), and they reported a significant increase in the concentration of 25(OH)D with both treatment regimens, as follows: monthly calcifediol treatments (0.266 mg/month) produced an increase from a mean (SD) of 23.3 (8.3) ng/mL to 38.8 (12.5) ng/mL, p < 0.001, and biweekly calcifediol treatments (0.266 mg/biweekly) produced an increase from a mean (SD) of 16.7 (9.3) ng/mL to 56.2 (18.5) ng/mL; p < 0.001 [18]. Similarly, a recent clinical trial, conducted by Pérez-Castrillon et al (2021), of postmenopausal women showed a mean (SD) 25(OH)D increase of 14.9 (8.1) ng/mL after four months of monthly treatments with calcifediol (0.266 mg (n = 200)) [16].…”

Calcifediol: Why, When, How Much?

“…Some common doses of calcifediol used in clinical practice have been shown to elevate serum 25(OH)D 3 levels above the physiological level, especially when taken intermittently. There is scientific evidence that such excessive values of 25(OH)D 3 could impact health and bone metabolism homeostasis negatively [ 90 , 91 , 92 ]. Toxicity associated with vitamin D overdose could be attributed both to the responsibility of health care providers (i.e., medical prescription or dispensing errors) or to errors in medicine self-administration by the patient.…”

Consenso Delphi sobre Estrategias Terapéuticas y de Prevención Sanitaria de la hipovitaminosis D

“…To this end, the experts agreed that, in addition to serum levels of 25(OH)D, the Body Mass Index (BMI) must be taken into account (considering the relationship between BMI and concentrations of 25(OH)D) 10 , the degree of habitual sun exposure of the patient and the use of certain drugs that can alter the absorption and catabolism of vitamin D 11 . There was also agreement that supplementation can be established on a weekly, fortnightly or monthly basis without affecting its efficacy 12,13 , and that it should be 800-1,000 IU/day in people over 65 years of age, to reach plasma concentrations enough of 25(OH)D 9 .…”

“…In this sense, many experts recognized that screening should only be carried out in patients with pathologies associated with hypovitaminosis D and in risk groups such as institutionalized elderly, as established by the recommendations. However, some of those surveyed believed that screening should be universal from the age of 18, a position that is possibly due to the high prevalence of hypovitaminosis D. Despite these discrepancies, there was agreement that measuring 25(OH)D levels was required in older people at risk of falls, in patients with osteoporosis with or without osteoporotic fracture, fragility fractures, chronic kidney disease, liver disorders or intestinal disease and in patients treated with drugs that can interact with vitamin D 6,12 . The experts also recognized that parathyroid hormone is a valid marker of vitamin D deficiency since there is an association between vitamin D deficiency and secondary hyperparathyroidism 2,3 .…”

“…Recently, the Spanish Medicines Agency has published an informative note on the appearance of hypercalcaemia due to cholecalciferol overdose in children and calcifediol in adults 36 , although the most recent studies on the use of calcifediol have not described any toxicity associated with this drug 12,37…”