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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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: The most frequent adverse effects of aromatase inhibitors (AI) are arthralgia and bone loss induction. These reduce the quality of life of patients and their adherence to the treatment. This study evaluates the early AI cessation caused by AI intolerance, and the evolution of joint pain and health-related quality of life (HRQoL) during AI treatment until 1-year after AI completion., Methods: Data of 910 women diagnosed with early breast cancer and candidates for AI were recruited in B-ABLE cohort. AI discontinuation was analyzed by survival analysis, including Kaplan-Meier estimation and Cox regression. Patients were distributed in three groups of the study according to previous tamoxifen (TAM) exposure and length of AI treatment: TAM-2yAI, TAM-3yAI, and 5yAI. Evolution of joint pain and HRQoL in osteoporosis was evaluated using Visual Analog Scale (VAS) and ECOS-16 tests, respectively, from baseline to 1-year after AI completion through repeated-measures ANOVA., Results: Risk of AI discontinuation was increased in patients previously exposed to tamoxifen compared to non-exposed (adjusted HR 5.30 [95% CI 2.23 to 12.57]). VAS and ECOS-16 scores of TAM-2yAI and TAM-3yAI groups increased during AI treatment, mainly during the first 3-12 months. After 1-year from AI completion, values tend to decrease to baseline levels. In 5yAI group, VAS and ECOS-16 levels increased at three months, and VAS remained significantly higher at 1-year post-treatment., Conclusions: AI therapy increased joint pain and reduced HRQoL, mainly during the first year of treatment. Patients previously treated with tamoxifen experienced greater pain when they switched to AI therapy and had an excess risk of discontinuation during the first 12 months., Trial Registration: ClinicalTrials.gov: NCT03811509. Registered 28 January 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03811509 .

Introduction: Breast cancer patients treated with aromatase inhibitors (AIs) experience increased bone loss during their treatment. However, there is little information about bone mineral density (BMD) after completing AI-treatment. The present study aimed to assess BMD changes one year after AI-therapy completion., Methods: Data were collected from 864 postmenopausal women treated with AI during 5 years (5y-AI group), or during 2-3 years after taking tamoxifen therapy (pTAM-AI group). Participants with osteoporosis were treated with oral bisphosphonates (BP). BMD changes in lumbar spine (LS), femoral neck (FN) and total hip (TH) between baseline, end of treatment, and at one year post-treatment were assessed using repeated-measures ANOVA., Results: At the end of AI-treatment, 382 patients had available BMD values and 316 also had post-treatment BMD values. As expected, BMD levels were decreased at AI-completion in non-BP treated patients. After one year, LS BMD increased in both groups (5y-AI: +2.11% [95%CI: 1.55 to 2.68], p < 0.001; pTAM-AI: +1.00% [95%CI: 0.49 to 1.51], p < 0.001) compared with the end of AI-therapy, while values at FN and TH remained stable. On the other hand, BMD values of BP-treated patients were increased or maintained at the end of AI-treatment and also at post-treatment., Conclusions: At one year after AI-completion, FN and TH BMD remained reduced in non-BP treated women, while LS BMD was recovered in the 5y-AI group and partially recovered in the pTAM-AI group. BP treatment increased or maintained BMD values at the end of therapy and at one year post-treatment., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Some patients experience fractures while receiving oral bisphosphonates (BPs) treatment. Clinical risk factors, advanced bone density loss, and microarchitecture deterioration have been associated with such fractures but bone tissue properties other than bone mineral density (BMD) have not been assessed., Methods: In a cross-sectional study of postmenopausal women on bisphosphonates for at least 4years with good adherence to treatment, 21 patients with incident fractures were compared with 18 treated patients without new fractures. Demographic and clinical variables, BMD, laboratory tests, and bone material strength index (BMSi) assessed by impact microindentation at the tibial diaphysis were recorded for all participants., Results: Clinical and laboratory results did not differ between patients taking BPs with incident fractures and those without new fractures. However, BMSi was significantly lower (mean±SD) in those who fractured (73.76±6.49) than in no-fracture patients (81.64±6.26; p=0.001). Lumbar spine (LS) BMD was also lower in fractured patients (p=0.03). Adjusted models including age, body mass index, years on BP treatment, and LS-BMD confirmed an increase in fracture risk per BMSi standard deviation decrease: adjusted OR 23.5 [95% CI 2.16 to 255.66], p=0.01. ROC analyses showed an area under the curve of 0.82 (95% CI 0.68 to 0.95) for BMSi, higher than that for BMD at any location, which ranged from 0.64 (95% CI 0.47 to 0.82) for femoral neck (FN) BMD to 0.71 (95% CI 0.55 to 0.87) for LS-BMD., Conclusions: Patients who fracture while receiving BPs treatment have worse BMSi scores than BP-treated patients without fractures. The potential for BMSi to provide an additional osteoporosis treatment target should be explored., (Copyright © 2017 Elsevier Inc. All rights reserved.)

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., (© 2016 Society for Endocrinology.)