Profile In Postmenopausal Women Research Articles

Effects of daily probiotic supplementation with Lactobacillus acidophilus on calcium status, bone metabolism biomarkers, and bone mineral density in postmenopausal women: a controlled and randomized clinical study.

Menopause poses significant health risks for women, particularly an increased vulnerability to fractures associated with osteoporosis. Dietary interventions have emerged as promising strategies, focusing on mitigating the risk of osteoporosis rather than solely addressing the established disease. This 12-week randomized controlled trial aimed to analyze the effects of consuming Lactobacillus acidophilus probiotics on calcium levels, biomarkers of bone metabolism, and bone mineral density (BMD) profiles in postmenopausal women. Fifty-five participants were randomly assigned to receive either a placebo (n = 25) or the probiotic L. acidophilus UALa-01™ (n = 30) daily via oral intervention. Throughout the study, evaluations included body composition, blood biochemical parameters, serum calcium levels, and biomarkers of bone metabolism. Additionally, Dual-energy X-ray absorptiometry was used to measure BMD profiles. The findings delineated that the probiotic group experienced a decrease in serum calcium levels compared to their initial levels. However, hair calcium levels and biomarkers related to bone metabolism showed no notable changes within this group. Consumption of probiotic L. acidophilus also seemed to prevent fluctuations in bone turnover markers. Moreover, there were no significant alterations in BMD levels at the lumbar spine, left femur, and total body in the probiotic group. Additionally, probiotic intake led to favorable outcomes by significantly reducing both body fat and visceral fat during the intervention period. Conversely, an adverse effect of consuming probiotic L. acidophilus was observed with a significant increase in glucose concentration. In conclusion, the consumption of L. acidophilus probiotics daily for 12 weeks among postmenopausal women does not affect the profile of BMD, but it may help in stabilizing bone turnover. It is important to note that most measured parameters were within the normal range for this population. However, it is worth noting that 3 months of probiotic supplementation could potentially disrupt calcium and glucose status in postmenopausal women.

Association of endogenous sex hormone levels with tooth loss due to periodontitis in men and post-menopausal women: Themulti-ethnic study of atherosclerosis.

To investigate the association between endogenous sex hormone levels and history of tooth loss related to periodontitis in healthy middle-aged to older men and post-menopausal women. This cross-sectional study included 5649 participants aged 45-84 (mean age, 63 ± 10 years) from the Multi-Ethnic Study of Atherosclerosis cohort who had sex hormone levels measured and answered a questionnaire regarding perceived periodontal status at exam 1. Multivariable logistic regression was used to examine the association of sex hormones (exposure) with history of tooth loss (outcome), stratified by sex. Among post-menopausal women, higher free testosterone (per 1SD) was associated with a greater prevalence of tooth loss [OR 1.49 (95% CI, 1.08-2.05)], whereas higher sex hormone binding globulin (SHBG) was associated with a lower prevalence of tooth loss [OR 0.74 (0.58-0.94)], after adjustment for cardiometabolic risk factors and reproductive factors. In men, higher free testosterone and lower SHBG were associated with a lower prevalent probability of tooth loss in unadjusted analysis, but these associations lost significance after covariate adjustment. A higher androgenic sex hormone profile in post-menopausal women (i.e., increased free testosterone, lower SHBG) was associated with an increased prevalence of tooth loss, after adjusting cardiometabolic risk factors. No such association was found in men. These findings suggest that sex hormones may influence or serve as a marker for periodontal health.

Comprehensive analysis of circRNA expression profiles in postmenopausal women differing in bone mineral density.

Postmenopausal osteoporosis (PMOP) seriously endangers the bone health of older women. Although there are currently indicators to diagnose PMOP, early diagnostic biomarkers are lacking. Circular ribonucleic acid (circRNA) has a stable structure, regulates gene expression, participates in the pathological process of disease, and has the potential to become a biomarker. The purpose of this study was to investigate circRNAs that could be used to predict patients with early PMOP. Ribonucleic acid (RNA) sequencing was performed on peripheral blood leukocytes from 15 female patients to identify differential circRNAs between different groups. Using bioinformatics analysis, enrichment analysis was performed to discover relevant functions and pathways. CircRNA-micro ribonucleic acid (miRNA) interaction analysis and messenger ribonucleic acid (mRNA) prediction and network construction help us to understand the relationship between circRNA, miRNA, and mRNA. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to validate the gene expression of candidate circRNAs. We screened out 2 co-expressed differential circRNAs, namely hsa_circ_0060849 and hsa_circ_0001394. By analyzing the regulatory network, a total of 54 miRNAs and 57 osteoporosis-related mRNAs were identified, which, as potential downstream target genes of hsa_circ_0060849 and hsa_circ_0001394, may play a key role in the occurrence and development of PMOP. The occurrence and development of PMOP is regulated by circRNAs, and hsa_circ_0060849 and hsa_circ_0001394 can be used as new diagnostic markers and therapeutic targets for early PMOP.

Effect of radiofrequency on postmenopausal adipose tissue: A randomized control trial

Aim. To determine the effect of radiofrequency on anthropometric measurements and lipid profile in postmenopausal women. Material and methods. Sixty postmenopausal women diagnosed as having abdominal adiposity and abnormal lipid profiles were incorporated into this study. Participants were assigned at random into two equal groups. Group A adhered to a Mediterranean diet and engaged in aerobic exercise for 12 weeks (n = 30), whereas group B followed a Mediterranean diet and participated in both aerobic exercise and radiofrequency treatments for the same 12-week period (n = 30). Both groups had their anthropometric measurements, encompassing weight, body mass index (BMI), and waist circumference, along with lipid profile components involving total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), very-low-density lipoprotein (VLDL), and triglycerides (TG), assessed before and after the 12-week program duration. Results. Significant improvements (p < 0.05) were noted in all outcome measures within both groups. Upon post-treatment comparison, both groups exhibited statistically significant reductions in all anthropometric measurements, LDL and TG (p < 0.05), while there was a statistically significant increase in HDL (p < 0.05) favoring group B. Nevertheless, there were no significant differences between groups for TC and VLDL (p > 0.05) after treatment. Conclusion. Radiofrequency has positive effect on anthropometric measurements and lipid profile in postmenopausal women.

Comprehensive Analysis of the Correlation between Estrogen Levels, Homocysteine, and Lipid Profiles in Postmenopausal Women with Coronary Heart Disease

Objective: To investigate the correlation between estrogen levels, blood homocysteine, and blood lipids in postmenopausal female patients with coronary heart disease. Methods: This study selected 50 postmenopausal female patients with coronary heart disease from Northeast Normal University Hospital (observation group). The data collection period extended from June 2021 to June 2023. Simultaneously, 50 healthy patients with no history of coronary heart disease were selected during the same period as the control group. Physical examinations were conducted for all participants. Estrogen levels, blood homocysteine, and blood lipid levels were tested in both groups. Results: Compared to the control group, the observation group exhibited higher levels of follicle-stimulating hormone (FSH), total cholesterol (TC), and homocysteine (Hcy), and lower levels of high-density lipoprotein cholesterol (HDL-C; P < 0.05). Pearson correlation analysis revealed a negative correlation between estradiol (E2) levels and changes in Hcy, TC, and low density lipoprotein cholesterol (LDL-C) levels (P < 0.01). Multivariate analysis indicated that E2 serves as a protective factor against coronary heart disease in postmenopausal women. Decreased E2 levels, LDL-C, and Hcy were identified as independent risk factors for coronary heart disease in women (P < 0.05). Conclusion: A declining trend in estrogen levels among postmenopausal women has implications for their blood lipid levels and is closely associated with the development of chronic complications of menopause.

Effect of fsh on lipid profile in postmenopausal women

The World Health Organization (WHO) and Stages of Reproductive Aging Workshop (STRAW) define menopause as a permanent endpoint of the menstrual cycle for one year that occurs naturally or by induction of surgical procedure, chemotherapy or radiation .The etiology of menopause is classified into physiological and non-physiological. Pathophysiology of menopause includes the decline of ovary function in menopause, response to a loss of ovarian feedback mechanism, and the decline of the hypothalamus and pituitary function. Endocrine changes in menopause lead to alteration of gonadotropin secretion cycle patterns, changes in steroid and peptide hormones through monophasic patterns to increase gonadotropin, and decreased estrogen .Aim: This study aims to investigate the effect of FSH on lipid profile in postmenopausal women. Study design: A cross-section observational study. Method: The study is a cross-sectional study done on 90 women. These women aged more than 50 years had cessation of menstrual cycle for over a year. The blood samples were taken from 90 postmenopausal women, and interviews were conducted using a questionnaire. FSH measure, by ElectroChemiLuminescence (ECL) technology for immunoassay analysis done by Cobas e411 device. Lipid profile measure, by manual techniques done by use of spectrophotometer device. Result: We observed increase in Follicle-stimulating hormone (FSH) during postmenopause has a positive significant correlation with body mass index (BMI) (r 0.350, p 0.001), total cholesterol (TC) (r 0.397, p 0.001) and Low-density lipoprotein (LDL) ( r 0.421, p 0.001) FSH also correlated positively but insignificant correlation with triglyceride (TG) (r 0.175, p 0.098) and very low-density lipoproteins (VLDL) ( r 0.055, p 0.604). FHS has a negative significant correlation with Estradiol ( r -0.509, p 0.001) and Vit.D( r-0.220, p 0.037) as well as FSH correlated negative but insignificant with age ( r -0.142, p 0.183) and High-density lipoprotein (HDL) (r -0.048, p 0.656). Conclusion: The current study showed a significant positive correlation of FSH with TC and LDL, an insignificant positive correlation with TG, and an insignificant negative correlation with HDL. Keywords: Postmenopause, FSH, Lituenizing Hormone, HDL

Whole-Body Cryotherapy Alters Circulating MicroRNA Profile in Postmenopausal Women.

The incidence of metabolic syndrome (MetS) increases with age, especially in women. The role of microRNAs (miRs) in the regulation of metabolism is postulated. The aim of the study is to identify miRs that may be markers of MetS and to assess changes in miRs expression as a result of 10 and 20 whole-body cryotherapy treatments (WBC; 3 min, -120 °C) in postmenopausal women with MetS (M-60, BMI 30.56 ± 5.38 kg/m2), compared to healthy postmenopausal (H-60, BMI 25.57 ± 2.46 kg/m2) and healthy young women (H-20, BMI 22.90 ± 3.19 kg/m2). In a fasting state, before 1 WBC and after 10 WBCs, as well as 20 WBCs, the expression of miR-15a-5p, miR-21-5p, miR-23a-3p, miR-146a-5p, miR-197-3p, miR-223-3p, fasting blood glucose (FBG) and blood lipid profile were determined. miR-15a-5p and miR-21-5p were down-regulated in M-60, while miR-23a-3p and miR-197-3p were up-regulated, and miR-223-3p down-regulated in M-60 and H-60, compared to H-20. Significant positive correlations between up-regulated (mostly for miR-23-3p and miR-197-3p) and significant negative correlations between down-regulated (mostly for miR-15a-5p) miRs and markers of body composition as well as metabolic disorders were observed. After 20 WBCs, miR-15a-5p expression was up-regulated in all groups. In H-60, down-regulation of miR-197-3p expression occurred after 10 WBCs and 20 WBCs. Following 10 WBCs, FBG decreased in all groups, which intensified in M-60 post-20 WBCs. In our research, it has been shown that miR-23a-3p and miR-197-3p are accurate markers of MetS and MetS risk factors, while miR-15a-5p and miR-23a-3p are precise markers of body composition disorders. WBC is an effective treatment for up-regulating miR-15a-5p and lowering glucose levels in young and postmenopausal women and down-regulating miR-197-3p expression in postmenopausal women. It may be an adjunctive effective treatment method in MetS and hyperglycemia.

Relationship between years since menopause and lipid variation in postmenopausal women: A cross-sectional study

Lipid alteration in postmenopausal women is commonly due to hormonal changes. This study aimed to explore the association between the years since menopause and lipid profiles in postmenopausal women. In this cross-sectional study, a total of 1033 postmenopausal women were recruited from the Women's Hospital of Zhejiang University in China between 2015 and 2022. Each participant was interviewed using questionnaires regarding sociodemographic and reproductive data. Anthropometric measurements, lipid profiles, and reproductive hormone levels were assessed. Participants were divided into 3 groups based on the length of time since menopause: 2, 2 to 5.9, and 6 years. Differences in lipid profiles and reproductive hormones among the groups were compared. Logistic and linear regression analyses were used to examine the relationship between years after menopause and lipid profile. High-density lipoprotein cholesterol (HDL-C) and luteinizing hormone levels were significantly lower in postmenopausal women with time since menopause of ≥6 years than those <2 years (P < .05), whereas low-density lipoprotein cholesterol levels were significantly higher (P < .05). A longer time after menopause was independently associated with lower HDL-C levels (β, -0.059, standard error, 0.023, P = .01) after adjustment for age, body mass index, and other confounders. Compared to women who had menopause for <2 years, those who were postmenopausal for >6 years had lower HDL-C levels after adjustment for age, body mass index, and other covariates (β, -0.123, 95% confidence interval, [-0.221, -0.014], P = .014). Longer time since menopause was associated with an atherogenic lipid profile with appreciably low levels of HDL-C subfraction. Future multicenter studies are necessary to examine postmenopausal population and determine how differences in lipids influence the risk of cardiovascular disease in this group.

The effects of phytosterol and phytostanol supplementation on the lipid profile in postmenopausal women: A systematic review and meta-analysis of randomized controlled trials.

Various studies have proven that phytosterols and phytostanols (PS) are lipid-lowering agents. These compounds play a role in regulating high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and triglyceride (TG) metabolism. Although various drugs are available and are currently used to treat dyslipidemia, the management of lipid abnormalities during the postmenopausal period remains a challenge. Thus, scientists are trying to develop new strategies to reduce serum lipids concentrations using natural products. However, the impact of PS administration on serum lipids in postmenopausal women remains unclear. Hence, the purpose of this study was to assess the effect of PS supplementation on the lipid profile in postmenopausal women based on a systematic review of the literature and a meta-analysis of randomized controlled trials. PubMed/Medline, Scopus, Embase, and Web of Science were searched to identify suitable papers published until January 18, 2022. We combined the effect sizes with the DerSimonian and Laird method using a random effects model. PS supplementation resulted in a significant decrease in TC (weighted mean difference [WMD]: -16.73 mg/dl) and LDL-C (WMD: -10.06 mg/dl) levels. No effect of PS supplementation on TG (WMD: -1.14 mg/dl) or HDL-C (WMD: -0.29 mg/dl) concentrations was detected. In the stratified analysis, there was a notable reduction in TC and LDL-C levels when the PS dose was ≥2 g/day (TC: -22.22 mg/dl and LDL-C: -10.14 mg/dl) and when PS were administered to participants with a body mass index ≥25 kg/m2 (TC: -20.22 mg/dl and LDL-C: -14.85 mg/dl). PS administration can decrease TC and LDL-C, particularly if the dose of administration is ≥2 g/day and if the participants are overweight or obese. Further high-quality studies are needed to firmly establish the clinical efficacy of PS usage in postmenopausal females.

Association of follicle stimulating hormone and serum lipid profiles in postmenopausal women.

The aim of the study was to observe the association between follicle stimulating hormone (FSH) levels and serum lipid profiles in postmenopausal women. A total of 411 healthy postmenopausal women with a mean age of 55 years (range 45–65 years) were enrolled in this study. Data on age, time of last menstrual period, past medical history, use of medications, and smoking status were collected, and body weight, height, and blood pressure were measured. Blood samples were collected to measure the serum concentrations of FSH, luteinizing hormone (LH), estradiol (E2), glucose, total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) using routine methods. FSH levels were negatively associated with LDL-C, even after adjustment for age, LH, E2, BMI, systolic blood pressure (SBP), and diastolic blood pressure (DBP) (OR = 0.185, 95% CI = 0.051‐0.669). Although FSH may also be negatively associated with dyslipidemia (P = .06 for trend) and hypercholesterolemia (P = .079 for trend), but no statistical significance was found after adjusting for confounding factors, particularly BMI. All relevant data are within the paper and its Supporting Information files. The results indicated that lower FSH levels might increase the odds of dyslipidemia, especially the risk of LDL-C elevation, which is an important factor that increases the risk of CVD in postmenopausal women.

STUDY OF FASTING PLASMA GLUCOSE AND LIPID PROFILE IN POSTMENOPAUSAL WOMEN

Objectives: The study was designed to determine fasting plasma glucose (FPG) and lipid profiles in postmenopausal women. Methods: 200 postmenopausal women were enrolled for the study and were compared to 100 normal healthy women of the same age from the Outdoor Patient Department of LN Medical College and research center of Bhopal city. Those fulfilling inclusion and exclusion criteria were enrolled for the study and the blood samples were analyzed for lipid profile and FPG. Results: Significant higher concentrations of total cholesterol (p&lt;0.001), triglyceride (p&lt;0.001), low-density lipoprotein (LDL) (p&lt;0.001), very LDLs (p&lt;0.001), and FPG (p&lt;0.001) were demonstrated in postmenopausal women when compared with normal healthy women. A significantly lower concentration of high-density lipoprotein (p&lt;0.001) was demonstrated in postmenopausal women when compared with normal healthy women. Conclusion: Menopausal transition and the related changes in the hormonal milieu (e.g., decreased systemic estradiol (E2) levels) are linked with adverse changes in several indicators of metabolic health. For instance, during the menopausal transition elevated blood glucose levels and adverse changes in serum lipids have been reported.

Evaluating the association between amino acid and acylcarnitine profiles and different levels of coronary artery disease risk in postmenopausal women using targeted metabolomics technique.

Postmenopausal women are at increased risk of developing coronary artery disease (CAD). Metabolomic approaches aim at discovering more helpful biomarkers of CAD to reduce the disease burden in the future. Here, we intend to find potential blood biomarkers, amino acids, and acylcarnitines in postmenopausal women with different severity of CAD by using high-throughput methods. This cross-sectional study was performed on postmenopausal women ( n = 183) who underwent coronary CT scans. Coronary artery calcium scoring (CACS) was assessed to detect plaque burden and degree of coronary artery obstruction. The participants were divided into three groups based on the score as follows (i) "low CACS" ( n = 96); a score of 0 to 10, (ii) "medium CACS" ( n = 35); a score between 11 and 100 and (iii) "high CACS" ( n = 52); a score greater than 100. Metabolites, including amino acids and acylcarnitines, were quantified using a targeted mass spectrometry method in serum samples. The association between metabolites and disease status was evaluated using univariate and multivariate regression analyses with adjustment for confounding factors. Factor analysis was used to deal with multiple comparisons. Metabolites, including proline, glutamic acid, and phenylalanine, were significantly lower in the high CACS group than the low CACS one. Also, a lower level of lysine and phenylalanine in high CACS compared with medium one was observed. Concerning acylcarnitines, it was found that C4 and C8:1 significantly were higher in women with high CACS. The logistic regression analysis revealed that the circulating levels of these metabolites (except C4) were associated with the presence of coronary artery calcification independently of age, body mass index, and time of menopause. Also, the amino acids were associated independently of medication and diabetes. The present study indicated that circulating levels of amino acids and acylcarnitines profile in postmenopausal women are partly associated with the severity of CAD in these participants.

Role of Phytoestrogen-Rich Bioactive Substances (Linum usitatissimum L., Glycine max L., Trifolium pratense L.) in Cardiovascular Disease Prevention in Postmenopausal Women: A Systematic Review and Meta-Analysis.

The aim of this report was to determine the impact of flaxseed, soy and red clover, and their bioactive substances on the lipid profile in postmenopausal women in cardiovascular diseases prevention. We used the following databases: MEDLINE (PubMed), EMBASE and the Cochrane Library. Meta-analysis indicates that the intake of flaxseed by postmenopausal women is associated with a statistically significant reduction in total cholesterol (TC) levels (weighted-mean difference (WMD) = −0.26; 95% confidence interval (95% CI): −0.38 to −0.13; p = 0.0001), low-density lipoprotein cholesterol (LDL-C) levels (WMD = −0.19; 95% CI: −0.30 to −0.08; p = 0.0006), and high-density lipoprotein cholesterol (HDL-C) levels (WMD = −0.06; 95% CI: −0.11 to −0.01; p = 0.0150). The effect of soy protein on the lipid profile showed a significant decrease in TC levels: WMD = −0.15; 95% CI: −0.25–0.05; p = 0.0048, LDL-C levels: WMD = −0.15; 95% CI: −0.25–0.05; p = 0.0067, as well as a significant increase in HDL-C levels: WMD = 0.05; 95% CI: 0.02–0.08; p = 0.0034. Changes in the lipid profile showed a significant reduction in TC levels after the use of red clover (WMD = −0.11; 95% CI: −0.18–−0.04; p = 0.0017) and a significant increase in HDL-C levels (WMD = 0.04; 95% CI: 0.01 to 0.07; p = 0.0165). This meta-analysis provides evidence that consuming flaxseed, soy and red clover can have a beneficial effect on lipids in postmenopausal women and suggest a favorable effect in preventing cardiovascular diseases.

Assessment of lipid profile in post menopausal women

Background: Younger age at menopause is associated with greater risk for coronary heart disease (CHD) and all-cause mortality. The present study was conducted to assess lipid profile in post menopausal women. Materials &amp; Methods: 80 women in age ranged 20-60 years were divided into 2 groups. Group I comprised of premenopausal women (20- 40 years) and group II post menopausal women (40-60 years). 5 ml of venous blood was withdrawn from anticubital vein with full aseptic precautions. Clear unhaemolysed serum was obtained by centrifugation. Estimation of serum lipids such as total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C), very low density lipoprotein (VLDL) was done. Results: The mean TC (mg/dl) in group I was 178.2 and in group II was 246.4, TG was 126.2 and 138.4, HDL- C was 62.4 and 42.8, LDL- C was 132.8 and 232.6 and VLDL was 26.2 and 28.0 in group I and II respectively. The difference was significant (P&lt; 0.05). Conclusion: Higher level of lipid profile in post menopausal women increases the risk of cardiovascular diseases.

The effect of vitamin D on the lipid profile as a risk factor for coronary heart disease in postmenopausal women: a meta-analysis and systematic review of randomized controlled trials

The exact effect of vitamin D administration on the lipid profile in postmenopausal women is unknown. However, as dyslipidemia is a recognized risk factor for coronary heart disease (CHD) in this population, the lipid-lowering effects of vitamin D need to be explored Thus, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the impact of vitamin D use on triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) as a risk factor for coronary heart disease (CHD) in postmenopausal women. We developed a search strategy for multiple databases (PubMed/Medline, Scopus, Embase, and Web of Science) to identify relevant RCTs whose results were published until June 1st, 2021. We combined the results using a random effects model (the DerSimonian and Laird random effects model). Lipid profile outcomes were expressed as weighted mean difference (WMD) and 95% confidence intervals (CIs) between intervention and comparator groups. Supplementation with vitamin D decreased TG (WMD: -3.55mg/dL, 95% CI: -5.34 to -1.76, P<0.001) in postmenopausal females versus controls. In the subgroup analyses, vitamin D increased TC when the treatment duration was ˂26weeks (WMD: 6.56mg/dL, 95% CI: 0.78 to 12.35, P=0.02) as compared to ≥26weeks (WMD: -2.06mg/dL, 95% CI: -5.49, 1.36, P=0.23) and in the participants with a BMI ≥30kg/m2 (WMD: 3.65mg/dL, 95% CI: 0.09, 7.22, P=0.044). Moreover, vitamin D increased HDL-C when the treatment duration was ˂26weeks (WMD: 2.67mg/dL, 95% CI: 0.66 to 4.68, P=0.009). In addition, vitamin D decreased LDL-C when the vitamin D dose was ˃400IU/day (WMD: -1.89mg/dL, 95% CI: -2.47 to -1.31, P<0.001) as compared to ≤400IU/day (WMD: 2.50mg/dL, 95% CI: -2.50, 7.52, P=0.327). Vitamin D administration on the lipid profile as a risk factor for CHD in postmenopausal women reduces TG. Its effects to lower LDL-C and increase HDL-C and TC levels are clinically negligible but should be investigated in future research. In addition, supplementation with vitamin D results in a clinically significant reduction in TG, particularly in postmenopausal females with hypertriglyceridemia at baseline.

Alterations in Haematological and Clotting Profile of Post-Menopausal Women in Benin City, Nigeria

Background: The cessation of ovarian functions at menopause and the accompanying decline in the production of ovarian steroid hormones creates a unique set of health concerns for women. Reductions in sex steroid levels, particularly oestrogen, have been associated with various diseases and conditions, including bleeding disorders, coronary heart disease (CHD), osteoporosis, cognitive dysfunction, urinary incontinence, hot flushes, and mood changes, among others.&#x0D; Objective: To determine changes in haemorheological and clotting profile in post-menopausal women.&#x0D; Methods: Two hundred participants comprising one hundred and fifty post-menopausal women and fifty healthy pre-menopausal control subjects were studied. The investigations carried out include whole blood viscosity, plasma viscosity, fibrinogen concentration, Prothrombin time (PT), Activated partial thromboplastin time with kaolin (APTTK) levels and complete blood count using standard methods.&#x0D; Results: The mean age (p = 0.01), platelet count (p = 0.013), neutrophil (p = 0.03), neutrophil to lymphocyte ratio (p = 0.045) and platelet to lymphocyte ratio (p = 0.044) in postmenopausal women were significantly higher while lymphocyte count (p = 0.004) was significantly lower in postmenopausal compared to premenopausal women. Similarly, plasma oestradiol (p = 0.001), plasma viscosity (p = 0.03), relative blood viscosity (p = 0.03), whole blood viscosity (p = 0.03) and PTTK (p = 0.04) were significantly lower among postmenopausal women compared to premenopausal control subjects.&#x0D; Conclusion: Relative plasma viscosity correlated positively with age. There were significantly lower levels of haemorheological and clotting profile in post-menopausal women. These changes may be due to age or a decline in circulating oestrogen levels.

Long-term effects of a combination of isoflavones, agnus castus and magnolia extracts on climacteric symptoms and cardiometabolic risk profile in postmenopausal women

Objective To evaluate the long-term effects of a combination of isoflavones, agnus castus and magnolia extracts (combined isoflavone compound [CIC]) on climacteric symptoms and cardiometabolic risk in symptomatic postmenopausal women. Methods This interventional, prospective study evaluated climacteric symptoms, mood and sleep disorders using the 21-item Greene Climacteric Scale (GCS) and 7-item Insomnia Severity Index (ISI) questionnaires; and cardiovascular, metabolic and thrombotic risk markers at baseline (T0) and after 12 months of CIC treatment (T1). Results In healthy postmenopausal women (N = 71), 12-month CIC treatment significantly reduced patient-reported vasomotor symptoms (100% vs. 17%), mood disorders (67% vs. 25%) and sleep disorders (89% vs. 19%%) (all p < .001) compared with baseline; and significantly improved GCS psychological, somatic, and vasomotor domain scores and ISI sleep disturbance scores (all p < .05). CIC significantly reduced systolic (p = .022) and diastolic blood pressure (p < .001), and heart rate (p < .001); glucose concentrations (p = .018), HOMA index (p = .013), and ALT (p = .035), homocysteine (p = .005) and NT-proBNP (p = .003) levels. Conclusions Long-term CIC therapy improved vasomotor symptoms, mood disorders, sleep disorders, hemodynamic measurements and cardiometabolic risk markers in healthy postmenopausal women. ClinicalTrials.gov Identifier NCT03699150.

Abstract OT2-11-03: AMEERA-1 : Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with alpelisib in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2-)PIK3CA-mutated advanced breast cancer

Abstract Background Amcenestrant is an optimized oral SERD with potent dual activity of ER antagonism and degradation resulting in inhibition of ER signaling. Amcenestrant monotherapy or combination with palbociclib showed antitumor activity and a favorable safety profile in postmenopausal women with heavily pretreated ER+/HER2- mBC. PIK3CA mutations are associated with endocrine resistance in ER+/HER2- patients (pts). Published data support the addition of the PI3Kα inhibitor alpelisib to SERD therapy for these pts. Methods AMEERA-1 (NCT03284957) is an open-label, non-comparative, dose escalation and dose expansion Phase 1/2 study of amcenestrant as monotherapy, then in combination with other anti-cancer targeted therapies. Parts F and G investigate safety run-in and dose expansion, respectively, of amcenestrant in combination with alpelisib. Postmenopausal women with ER+/HER2- advanced breast cancer, PIK3CA mutated in tumor tissue or cfDNA, ECOG performance status 0-1, and ≥ 6 months prior endocrine therapy are eligible. Pts must have progressed on an aromatase inhibitor plus CDK4/6 inhibitor as first-line therapy for advanced disease. Part F allows ≤ 1 prior chemotherapy for advanced disease; no prior chemotherapy is allowed in Part G. Exclusion criteria in Parts F and G include prior drugs targeting the PI3K axis, type 1 diabetes, uncontrolled type 2 diabetes, history of severe cutaneous reactions, and ongoing osteonecrosis of the jaw. Part F assesses dose-limiting toxicities and pharmacokinetics (PK) of a standard dose of amcenestrant plus the approved dose of alpelisib (300 mg once daily). Additional amcenestrant doses or a lower dose of alpelisib may be explored based on safety and PK. The primary objective in Part F is to confirm the recommended phase 2 dose (RP2D) of amcenestrant in combination with alpelisib, based on safety. In Part G, approximately 34 pts will be treated at the RP2D, the primary endpoint being safety and tolerability. Secondary endpoints include PK and antitumor activity. This study is currently recruiting participants. This abstract was previously submitted to the 2021 European Society for Medical Oncology Annual Congress. Funding: Sanofi. Citation Format: Mario Campone, Aditya Bardia, Peter Kabos, Sarat Chandarlapaty, Patrick Neven, Valentina Boni, Simon Lord, Sylvaine Cartot-Cotton, Marina Celanovic, Alice Gosselin, Vasiliki Pelekanou, Hannah M Linden. AMEERA-1 : Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with alpelisib in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2-)PIK3CA-mutated advanced breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-11-03.

Abstract OT2-11-02: Ameera-1 Arm 4: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with everolimus in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer

Abstract Background Amcenestrant (SAR439859) is an optimized oral SERD with potent dual activity that antagonizes and degrades the ER, resulting in inhibition of the ER signaling pathway. Amcenestrant, as monotherapy or in combination with palbociclib, has shown antitumor activity and a favorable safety profile in postmenopausal women with heavily pretreated ER+/HER2- advanced breast cancer. Published data support the addition of targeted therapy to endocrine therapy for patients with ER+/HER2- advanced breast cancer. The objective of Arm 4 of the AMEERA-1 study is to evaluate safety and antitumor activity of amcenestrant in combination with the mammalian target of rapamycin (mTOR) inhibitor everolimus for patients with ER+/HER2- advanced breast cancer. Methods AMEERA-1 (NCT03284957) is an open-label, non-comparative, dose escalation and dose expansion Phase 1/2 study of amcenestrant as monotherapy, then in combination with other anti-cancer targeted therapies. Arm 4 investigates dose escalation (Part H) and dose expansion (Part I), of amcenestrant in combination with everolimus. Postmenopausal women with ER+/HER2- advanced breast cancer, ECOG performance status 0-1, and ≥ 6 months prior endocrine therapy are eligible. In Arm 4 (Parts H and I), ≤ 1 prior line of a single endocrine therapy for advanced disease is allowed. Patients must have progressed on a non-steroidal aromatase inhibitor plus cyclin-dependent kinase 4/6 inhibitor as first-line therapy for advanced disease. Prior treatment with fulvestrant or any other SERD is not allowed. Part H allows ≤ 1 prior chemotherapy for advanced disease; no prior chemotherapy for advanced disease is allowed in Part I. Exclusion criteria in Arm 4 include prior drugs targeting the phosphoinositide 3-kinase axis; history of or concurrent pneumonitis; history of severe cutaneous reactions; type 1 diabetes; uncontrolled type 2 diabetes; uncontrolled hypercholesterolemia, hypertriglyceridemia, and hyperglycemia; any uncontrolled infection; uncontrolled stomatitis, angioedema due to angiotensin-converting enzyme inhibitors, and impaired wounds. Part H evaluates the selected amcenestrant dose for combination therapy plus everolimus 10 mg once daily (QD) (the approved standard dose) or everolimus 5 mg QD, taken in 28-day cycles. Additional amcenestrant doses may be explored based on safety and pharmacokinetics (PK). The objective of Part H is to determine the recommended dose (RD) of everolimus in combination with the selected amcenestrant dose for combination therapy, based on preliminary safety, PK, and antitumor activity data. The primary endpoint in Part H is the incidence of treatment-related dose-limiting toxicities (DLTs) at Cycle 1. Approximately up to 12 DLT-evaluable patients will be needed to establish the RD of everolimus in combination with amcenestrant in Part H. In Part I, approximately 12 patients will be treated at the RD of everolimus for combination therapy with amcenestrant, the primary endpoint being safety and tolerability. Secondary endpoints include PK and antitumor activity. Funding: Sanofi. Citation Format: Mario Campone, Patrick Neven, Katarina Petrakova, Sofia Braga, Marina Celanovic, Patrick Cohen, Alice Gosselin, Sylvaine Cartot-Cotton, Vasiliki Pelekanou, Valentina Boni. Ameera-1 Arm 4: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with everolimus in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-11-02.

Abstract OT2-11-04: Ameera-1 Arm 5: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with abemaciclib in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer

Abstract Background Endocrine therapy in combination with a targeted cyclin-dependent kinase (CDK) 4/6 inhibitor is the clinical standard for treatment of ER+/HER2- advanced breast cancer. Amcenestrant (SAR439859) is an optimized oral SERD with potent dual activity that antagonizes and degrades the ER, resulting in inhibition of the ER signaling pathway. In previous arms of the AMEERA-1 study, amcenestrant, as monotherapy or in combination with the CDK4/6 inhibitor palbociclib, demonstrated antitumor activity and a favorable safety profile in postmenopausal women with heavily pretreated ER+/HER2- advanced breast cancer. The objective of Arm 5 of the AMEERA-1 study is to evaluate safety and antitumor activity of amcenestrant in combination with the CDK4/6 inhibitor abemaciclib for patients with ER+/HER2- advanced breast cancer. Methods AMEERA-1 (NCT03284957) is an open-label, non-comparative, dose escalation and dose expansion Phase 1/2 study of amcenestrant as monotherapy, then in combination with other anti-cancer targeted therapies. Arm 5 investigates dose escalation (Part J) and dose expansion (Part K), of amcenestrant in combination with abemaciclib. Postmenopausal women with ER+/HER2- advanced breast cancer, ECOG performance status 0-1, and ≥ 6 months prior endocrine therapy are eligible. In Arm 5 (Parts J and K), ≤ 1 prior line of a single endocrine therapy for advanced disease is allowed. Prior treatment with fulvestrant or any other SERD is not allowed; in addition, prior therapy with CDK4/6 inhibitors for advanced disease is not allowed. Part J allows ≤ 1 prior chemotherapy for advanced disease, while prior chemotherapy for advanced disease is not allowed in Part K. Additional exclusion criteria in Arm 5 are prior drugs targeting the phosphoinositide 3-kinase axis; history of or concurrent pneumonitis; and history of or concurrent venous thromboembolism (i.e., deep vein thrombosis, pulmonary embolism, or cerebral venous sinus thrombosis). Part J evaluates the selected amcenestrant dose for combination therapy plus abemaciclib 150 mg twice daily (BID) (the approved standard dose) or abemaciclib 100 mg BID, taken in 28-day cycles. Additional dose levels of amcenestrant may be explored based on safety and pharmacokinetics (PK). The objective of Part J is to determine the recommended dose (RD) of abemaciclib in combination with the selected amcenestrant dose for combination therapy, based on preliminary safety, PK, and antitumor activity data. The primary endpoint in Part J is the incidence of treatment-related dose-limiting toxicities (DLTs) at Cycle 1. Approximately up to 12 DLT-evaluable patients will be needed to establish the RD of abemaciclib in combination with amcenestrant in Part J. In Part K, approximately 20 patients will be treated at the RD of abemaciclib for combination therapy with amcenestrant, the primary endpoint being safety and tolerability. Secondary endpoints include PK and antitumor activity. Funding: Sanofi. Citation Format: Mario Campone, Sarat Chandarlapaty, Aditya Bardia, Patrick Neven, Katarina Petrakova, Peter Kabos, Valentina Boni, Sofia Braga, Marina Celanovic, Patrick Cohen, Alice Gosselin, Sylvaine Cartot-Cotton, Vasiliki Pelekanou, Hannah Linden. Ameera-1 Arm 5: Phase 1/2 study of amcenestrant (SAR439859), an oral selective estrogen receptor (ER) degrader (SERD), with abemaciclib in postmenopausal women with ER+/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-11-04.