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Introduction: In postmenopausal women, vitamin D deficiency has been associated with disability, low muscle mass and fractures. Irisin is an important myokine that may contribute to the maintenance of muscle and bone density. Vitamin D is associated with the growth and function of muscle tissue through interactions between the vitamin D receptor and PGC-1α and activation of p38/MAPK (mitogen-activated protein kinase) in muscle, a mechanism similar to irisin action. The aim of this pilot study was to evaluate the effects of cholecalciferol supplementation on serum irisin levels in sedentary postmenopausal women with hypovitaminosis D (25(OH)D < 20 ng/mL). Material and methods: 80 sedentary postmenopausal women with hypovitaminosis D and low sun exposure were supplemented with cholecalciferol (30,000 IU/month) for 12 months. Calcium, parathyroid hormone, alkaline phosphatase (AP) and irisin levels were measured before and after supplementation. Results: 25(OH) vitamin D increased in all participants. Serum levels of irisin increased (from 0.52 ± 0.27 to 0.80 ± 0.53; p < 0.003), accompanied by a decrease in AP (from 80 ± 24 to 66 ± 23; p < 0.001). Conclusions: Restoration of vitamin D status increased serum irisin levels in sedentary postmenopausal women. Whether increased serum irisin levels may have an impact on clinical outcomes deserves further evaluation.

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Laser therapy has been proposed to improve the symptoms of genitourinary syndrome of menopause (GSM), especially in women who do not accept hormonal therapy or are at a high risk of complications if they undergo hormonal therapy. However, studies evaluating the effectiveness and safety of laser treatment for GSM have shown controversial results. Thus, we aimed to determine the efficacy and safety of laser therapy in post-menopausal women with GSM. We have developed a protocol according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol using the population, intervention, comparison, outcome, and study design (PICOS) framework for post-menopausal women who have received no treatment, laser therapy, placebo, or vaginal estrogen for GSM. As per our protocol, randomized controlled trials and quasi-randomized trials, regardless of language of publication, will be searched in PubMed, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, and clinicaltrials.gov. Gray literature will be searched in Open Gray and Google Scholar. The reference lists will be scanned for additional trials, and the authors will be contacted if necessary. Outcome data reported in a trial registry, even when no published results were available, will be analyzed. The search will be performed using key terms, such as "post-menopausal women," "menopausal genitourinary syndrome," "vulvovaginal atrophy," and "laser therapy." Two review authors will independently screen the titles and abstracts, while three others will independently evaluate the full text of each study to determine its eligibility for this systematic review (SR). Any disagreement will be resolved through discussion and consensus. Data extraction will be performed independently using a standardized data collection form. Clinical outcomes, including vaginal atrophy, vaginal pH, dryness, dyspareunia, itching, burning, dysuria, urinary frequency, urinary urgency, and urinary incontinence, will be systematically evaluated. We will not perform a separate search for adverse effects; instead, we will consider the adverse effects described in the included studies. Furthermore, we will summarize the effects of dichotomous outcomes as risk ratios with 95% confidence intervals. On the other hand, continuous outcomes will be summarized by expressing treatment effects as a mean difference with standard deviation or as a standardized mean difference when different scales were used to measure the same outcome. We will use the Cochrane Risk of Bias 2 tool for bias assessment and the Grading of Recommendations Assessment, Development and Evaluation approach to rate the overall certainty of evidence. Review Manager 5.3.5 will be used for quantitative data synthesis, subgroup analysis, sensitivity analysis, meta-regression, and risk of bias assessment. The SR findings will provide highly relevant evidence through the synthesis of well-designed and robust clinical trials on the effectiveness and safety of laser therapy in GSM. The Prospective Register of Systematic Reviews (PROSPERO) registration number (2021) of the SR is CRD42021253605.

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BACKGROUND: The addition of everolimus to exemestane therapy significantly improves progression-free survival in postmenopausal patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant breast cancer. However, the safety profile of this schedule still might be optimized. METHODS: Patients included in the BALLET trial were assessed. The objectives of this analysis were to provide additional information on the safety profile of this schedule depending on prior anticancer therapies and to characterize the time course of adverse events (AEs) and serious AEs (SAEs) of clinical interest throughout the study period. Non-infectious pneumonitis (NIP), stomatitis, asthenia and weight loss were selected as AEs of clinical interest. RESULTS: The safety population of this analysis comprised 2131 patients. There were similar incidences of AEs and SAEs of clinical interest regardless of previous anticancer therapies. Most stomatitis and asthenia events occurred within the first three months. Incidence of weight loss appeared to plateau except in the case of grade 3-4 events, which occurred rarely. The incidence of any grade NIP (between 2 to 6%) and grade 3-4 NIP (between 0 to 1%) was low across the study, but steady. CONCLUSIONS: Everolimus plus exemestane is a well-known therapeutic option for aromatase inhibitor pretreated advanced breast cancer patients, and its toxicity profile is similar to that described in previous studies. Close monitoring, especially within the first three months, early intervention with preventive measures and patient education to help recognize the first signs and symptoms of AEs, will help to reduce their incidence and severity.

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BACKGROUND: Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population. PATIENTS AND METHODS: Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain. RESULTS: Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE. CONCLUSION: The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trials.

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OBJETIVO: comparar a qualidade de vida relacionada à saúde de mulheres na pós-menopausa praticantes de atividade física com e sem o diagnóstico de osteoporose. MÉTODOS: trata-se de estudo descritivo transversal, realizado por meio de entrevistas, em que o pesquisador aplicou uma ficha de avaliação e o questionário SF-36. Todas as voluntárias mulheres participaram do estudo por meio de um contato prévio por telefone. As características e objetivos da entrevista foram explicadas, além de confirmar o estágio pós-menopausa da voluntária. Formaram-se dois grupos, com 21 voluntárias cada um: grupo 1, constituído por mulheres sem osteoporose (64,38 ± 4,24 anos), e grupo 2, constituído por mulheres com osteoporose (67,81± 4,19 anos). Cada voluntária, inicialmente, submetia-se a uma ficha de avaliação para obtenção dos dados pessoais, história clínica, comorbidades e cuidados com a saúde. Em seguida, aplicava-se o questionário SF-36. Para avaliação das diferenças entre os grupos, aplicou-se o teste não-paramétrico de Wilcoxon. RESULTADOS: houve diferença significativa (p < 0,05) entre os grupos em relação aos componentes Aspectos Físicos e Estado Geral da Saúde do SF-36, com desempenho melhor para o grupo 1. CONCLUSÃO: mulheres na pós-menopausa com diagnóstico de osteoporose, mas que não tiveram fraturas, podem ter qualidade de vida semelhante à de mulheres na pós-menopausa sem osteoporose.

OBJECTIVE: to investigate the quality of life among physically active post-menopausal women with and without a diagnosis of osteoporosis. METHODS: a cross-sectional descriptive study was carried out through interview. All the participating women volunteered to take part of this study through previous contact by telephone. The characteristics and objectives of the inter view were explained in addition to confirmation of their postmenopausal status. There were two groups of 21 volunteers each: group 1 were non-osteoporotic women (64.38 ± 4.24 years-old) and group 2 were osteoporotic women (67.81 ± 4.19 years-old). Each volunteer was asked to fulfill a preliminary form in order to register personal information, clinical history, co-morbidities and health care. Following, the SF-36 questionnaire was applied. The Wilcoxon rank-sum test was used to assess differences between the two groups. RESULTS: there was a significant difference (p < 0.05) between both groups only with regard to the "Role Physical" and "General Health " components of the SF-36 form showing a better performance to group 1. CONCLUSION: post-menopausal women with a diagnosis of osteoporosis that did not sustain a fracture may present a similar quality of life, as compared to non-osteoporotic post-menopausal women.

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