1.
Calcifediol Treatment and COVID-19-Related Outcomes.
Nogues, X, Ovejero, D, Pineda-Moncusí, M, Bouillon, R, Arenas, D, Pascual, J, Ribes, A, Guerri-Fernandez, R, Villar-Garcia, J, Rial, A, et al
The Journal of clinical endocrinology and metabolism. 2021;(10):e4017-e4027
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Abstract
CONTEXT COVID-19 is a major health problem because of saturation of intensive care units (ICU) and mortality. Vitamin D has emerged as a potential treatment able to reduce the disease severity. OBJECTIVE This work aims to elucidate the effect of 25(OH)D3 (calcifediol) treatment on COVID-19-related outcomes. METHODS This observational cohort study was conducted from March to May 2020, among patients admitted to COVID-19 wards of Hospital del Mar, Barcelona, Spain. A total of 930 patients with COVID-19 were included; 92 were excluded because of previous calcifediol intake. Of the remaining 838, a total of 447 received calcifediol (532 μg on day 1 plus 266 μg on days 3, 7, 15, and 30), whereas 391 were not treated at the time of hospital admission (intention-to-treat). Of the latter, 53 patients were treated later during ICU admission and were allocated in the treated group in a second analysis. In healthy individuals, calcifediol is about 3.2-fold more potent on a weight basis than cholecalciferol. Main outcome measures were ICU admission and mortality. RESULTS ICU assistance was required by 102 (12.2%) participants. Out of 447 patients treated with calcifediol at admission, 20 (4.5%) required the ICU, compared to 82 (21%) out of 391 nontreated (P < .001). Logistic regression of calcifediol treatment on ICU admission, adjusted by age, sex, linearized 25-hydroxyvitamin D levels at baseline, and comorbidities showed that treated patients had a reduced risk of requiring the ICU (odds ratio [OR] 0.13; 95% CI 0.07-0.23). Overall mortality was 10%. In the intention-to-treat analysis, 21 (4.7%) out of 447 patients treated with calcifediol at admission died compared to 62 patients (15.9%) out of 391 nontreated (P = .001). Adjusted results showed a reduced mortality risk with an OR of 0.21 (95% CI, 0.10-0.43). In the second analysis, the obtained OR was 0.52 (95% CI, 0.27-0.99). CONCLUSION In patients hospitalized with COVID-19, calcifediol treatment significantly reduced ICU admission and mortality.
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AI-related BMD variation in actual practice conditions: A prospective cohort study.
Rodríguez-Sanz, M, Prieto-Alhambra, D, Servitja, S, Garcia-Giralt, N, Garrigos, L, Rodriguez-Morera, J, Albanell, J, Martínez-García, M, González, I, Diez-Perez, A, et al
Endocrine-related cancer. 2016;(4):303-12
Abstract
The aim of the study was to evaluate the progression of bone mineral density (BMD) during 3 years of aromatase inhibitors (AI) therapy in actual practice conditions. This prospective, clinical cohort study of Barcelona-Aromatase induced Bone Loss in Early breast cancer (B-ABLE) assessed BMD changes during 3 years of AI treatment in women with breast cancer. Patients with osteoporosis (T score < -2.5 or T score ≤ -2.0) and a major risk factor and/or prevalent fragility fractures were treated with oral bisphosphonates (BPs). Of 685 women recruited, 179 (26.1%) received BP treatment. By the third year of AI therapy, this group exhibited increased BMD in the lumbar spine (LS; 2.59%) and femoral neck (FN; 2.50%), although the increase was significant only within the first year (LS: 1.99% and FN: 2.04%). Despite BP therapy, however, approximately 15% of these patients lost more than 3% of their baseline bone mass. At 3 years, patients without BP experienced BMD decreases in the LS (-3.10%) and FN (-2.79%). In this group, BMD changes occurred during the first (LS: -1.33% and FN: -1.25%), second (LS: -1.19% and FN: -0.82%), and third (LS: -0.57% and FN: -0.65%) years of AI treatment. Increased BMD (>3%) was observed in just 7.6% and 10.8% of these patients at the LS and FN, respectively. Our data confirm a clinically relevant bone loss associated with AI therapy amongst nonusers of preventative BPs. We further report on the importance of BMD monitoring as well as calcium and 25-hydroxy vitamin D supplementation in these patients.
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Skeletal adverse effects with aromatase inhibitors in early breast cancer: evidence to date and clinical guidance.
Servitja, S, Martos, T, Rodriguez Sanz, M, Garcia-Giralt, N, Prieto-Alhambra, D, Garrigos, L, Nogues, X, Tusquets, I
Therapeutic advances in medical oncology. 2015;(5):291-6
Abstract
Aromatase inhibitors (AIs) are routinely used in the adjuvant treatment of women with hormone receptor-positive early breast cancer. Patients who receive AIs have an increased risk of bone loss and arthralgia compared with those treated with tamoxifen. In addition to the effects of AIs, the population of women with early breast cancer has a high prevalence of 25-hydroxyvitamin D (25(OH)D) insufficiency. In our experience 88% of patients had concentrations lower than 30 ng/ml. Vitamin D supplementation should be adapted to the baseline concentration. Another relevant finding in our research program was the close relationship between 25(OH)D levels and intensity of AI-related arthralgia (AIrA). A target concentration of 40 ng/ml 25(OH)D may prevent development of AIrA. We also demonstrate that AIrA is genetically determined: single nucleotide polymorphisms located in genes encoding key factors for the metabolism of estrogens and vitamin D (CYP17A1, VDR, and CYP27B1) are associated with self-reported arthralgia during AI therapy. We recommend establishing an individualized protocol of bone-health surveillance based on baseline and evolutionary clinical variables.
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Enhancing the bioactivity of polymeric implants by means of cold gas spray coatings.
Gardon, M, Melero, H, Garcia-Giralt, N, Dosta, S, Cano, IG, Guilemany, JM
Journal of biomedical materials research. Part B, Applied biomaterials. 2014;(7):1537-43
Abstract
Nanostructured anatase coatings were built-up on biocompatible polyetheretherketone (PEEK) by means of cold gas spray (CGS). Titanium layer was previously desposited, which acted as bond coat between PEEK and metal oxide. Semicrystalline polymer was not degraded during the spraying process and starting composition of titanium dioxide was not affected. TiO₂ was homogeneously obtained onto CGS Ti layer and completely covered the piece. Primary human osteoblasts were seeded onto biomaterials and in vitro cell experiments provided evidence to confirm that nanostructured anatase coatings deposited by cold gas spray improve the performance of PEEK implants.