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Denosumab vs. zoledronic acid treatment in post-menopausal breast cancer: a 2-year prospective observational study.
Buch-Larsen, K, Jørgensen, NR, Jensen, LT, Andersson, M, Schwarz, P
Scandinavian journal of clinical and laboratory investigation. 2021;(6):425-431
Abstract
Adjuvant treatment for post-menopausal women with early breast cancer (BC) includes aromatase inhibitors (AI), known to decrease bone mineral density (BMD). In this study, we investigate whether denosumab is a valid second option for patients unable to receive standard adjuvant i.v. zoledronic acid (ZA). In total, 212 patients have been evaluated after they did not receive ZA. Of those 194 were included. After evaluation by an endocrinologist, all patients were offered ZA as their first choice and 15% accepted (N = 29). The remaining 85% were offered denosumab (N = 165). All patients were followed prospectively with blood tests up to 24 months. DXA scans were performed at baseline and 24 months. No difference was observed between the two treatment groups at baseline, with regard to anthropometry and standard biochemistry. Markers of bone turnover (p-PINP, p-CTX, p-bone-specific alkaline phosphatase and p-osteocalcin) all showed significant suppression compared to baseline and remained suppressed throughout the 2 years. BMD showed small and significant increases at the spine (0.024 g/cm2) and total hip (0.019 g/cm2) in the denosumab group but no change at the femoral neck(-0.011g/cm2). In the ZA group, we observed no significant change at the spine (0.015 g/cm2) and total hip (-0.001g/cm2) and a small significant decrease at the femoral neck (-0.037 g/cm2). However, when we compared BMD change between the treatment groups, we found no significant difference.Conclusions: Our data indicate that for BC patients in AI treatment who refused or were not able to receive ZA treatment, denosumab might be recommended as a second choice. Regarding markers of bone turnover and BMD denosumab is equal to ZA.Summary: Women with early breast cancer receiving anti-estrogen treatment are at risk of developing osteoporosis.We followed 194 women receiving zoledronic acid (ZA) or denosumab for up to 2 years.We find that with regard to bone protection, denosumab is a viable alternative to ZA and might be recommended as a second choice.
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Energy-restricted Central-European diet stimulates liver microsomal function in obese postmenopausal women - a randomized nutritional trial with a comparison to energy-restricted Mediterranean diet.
Szczepanik, M, Malesza, IJ, Bajerska, J, Chmurzyńska, A, Muzsik, A, Bermagambetova, S, Mądry, E, Walkowiak, J, Lisowska, A
European review for medical and pharmacological sciences. 2020;(21):11165-11171
Abstract
OBJECTIVE Obesity and metabolic syndrome are risk factors for liver diseases like non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. A healthy food pattern is vital for managing these health problems, therefore, this study investigated how two calorie-restricted diets, the Central European diet (CED) and Mediterranean diet (MED), altered microsomal liver function in obese postmenopausal women with a risk of metabolic syndrome. PATIENTS AND METHODS One-hundred-forty-four subjects were randomly assigned to the CED (n=72) or the MED (n=72) groups. A 13C-methacetin breath test was performed, before and after the intervention to assess CPDR (Cumulative Percentage Dose Recovery at 120 minutes of the test), TTP (Time to Peak - maximal momentary recovery of 13C) and Vmax (the maximum momentary 13C recovery). RESULTS There was a statistically significant increase in TTP and Vmax in the CED group only (p=0.0159 and p=0.0498, respectively). Changes in CPDR and TTP due to intervention were significantly higher in the CED group than in the MED group (p=0.0440 and p=0.0115, respectively). CONCLUSIONS This is the first study to document a stimulatory effect of the energy-restricted CED on liver microsomal function as compared to MED. The relatively short dietary intervention led to a significant difference in the CYP1A2 activity between groups. The trial was registered in the German Clinical Trials Register (DRKS-ID: DRKS00012958; URL: https://www.germanctr.de/).
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Race-specific associations of 25-hydroxyvitamin D and parathyroid hormone with cardiometabolic biomarkers among US white and black postmenopausal women.
Xia, J, Tu, W, Manson, JE, Nan, H, Shadyab, AH, Bea, JW, Cheng, TD, Hou, L, Song, Y
The American journal of clinical nutrition. 2020;(2):257-267
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Abstract
BACKGROUND Concentrations of 25-hydroxyvitamin D [25(OH)D] tend to be lower in African Americans than in non-Hispanic whites, but whether adding information on parathyroid hormone (PTH) can help explain the higher cardiometabolic risk among African Americans is unknown. OBJECTIVES This study examined race (black/white)-specific independent and joint associations of 25(OH)D and PTH with cardiometabolic biomarkers including high-sensitivity C-reactive protein (hs-CRP), estimated glomerular filtration rate (eGFR), and homeostasis model assessment of insulin resistance (HOMA-IR) and β-cell function (HOMA-B). METHODS Among 1500 white and 1300 black postmenopausal women without cardiovascular disease from the Women's Health Initiative Observational Study, a weighted linear regression analysis and a novel penalized spline-based semiparametric model with contour plots, accounting for possible nonlinear relations and interactions simultaneously, were used to investigate the race-specific independent and joint associations of 25(OH)D and PTH with each biomarker. RESULTS Black women had lower concentrations of 25(OH)D and higher PTH, HOMA-IR, HOMA-B, hs-CRP, and eGFR than white women (all P values < 0.0001). Lower 25(OH)D and higher PTH were each independently and jointly associated with higher HOMA-IR in both white and black women, whereas a similar joint relation with HOMA-B was observed in white women only. In contrast, PTH was nonlinearly associated with HOMA-B in black women and positively associated with hs-CRP in white women, independently of 25(OH)D. Whereas there was an inverse linear relation between PTH and eGFR in white women after accounting for 25(OH)D, PTH and 25(OH)D were jointly and nonlinearly associated with eGFR in black women. CONCLUSIONS We found that the joint association of 25(OH)D and PTH with β-cell function, systemic inflammation, and kidney function apparently differed between white and black women. Further studies are needed to determine whether differences in the vitamin D-PTH endocrine system contribute to racial disparities in cardiovascular health.
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Comparison of the effect of lavender and bitter orange on anxiety in postmenopausal women: A triple-blind, randomized, controlled clinical trial.
Farshbaf-Khalili, A, Kamalifard, M, Namadian, M
Complementary therapies in clinical practice. 2018;:132-138
Abstract
INTRODUCTION This trial compared the effects of lavender and bitter orange on anxiety in postmenopausal women. METHODS This trial was conducted in 2015. Eligible postmenopausal women were allocated into one of two intervention groups or a control group (n = 52 per group) in a 1:1:1 ratio using a randomized block design. Intervention groups received 500 mg capsules containing only bitter orange or lavender flower powder, and the control group received 500 mg capsules containing starch. The Spielberger's State -Trait Anxiety Inventory (STAI) was used before and eight weeks after starting the intervention. Data analyses were based on intention to treat. RESULTS A one-way ANOVA showed no significant difference in mean state anxiety (P = 0.254) and trait anxiety (p = 0.972) score among the three groups before the intervention. The general linear model, adjusted for baseline state and trait anxiety scores and confounding factors, showed significant differences among the groups in the mean state anxiety (P = 0.010) and trait anxiety (p = 0.041) score after eight weeks of treatment. Bitter orange significantly reduced the mean state-anxiety scores compared with the control group [Adjusted Mean Difference (aMD): -1.99 (95% Confidence Interval, -3.64 to -0.34)]. Lavender significantly reduced the mean state-anxiety scores compared with the control group as well [aMD: -2.45 (95% CI -4.13 to -0.77)] and Bitter orange significantly reduced the mean trait-anxiety scores compared with the control group [aMD: -1.76 (95% CI -3.45 to -0.06)]. Lavender significantly reduced the mean trait-anxiety scores compared with the control group as well [aMD: -2.05 (95% CI -3.76 to -0.33)]. There was no significant difference between bitter orange and lavender groups after intervention in the mean trait-anxiety (p = 0.731) or state-anxiety (p = 0.578) scores. CONCLUSION The positive effect of bitter orange and lavender on anxiety in postmenopausal women suggests that they can be used to decrease anxiety in such women.
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Comparison of Changes in the Lipid Profiles of Eastern Chinese Postmenopausal Women With Early-Stage Breast Cancer Treated With Different Aromatase Inhibitors: A Retrospective Study.
Tian, W, Wu, M, Deng, Y
Clinical pharmacology in drug development. 2018;(8):837-843
Abstract
Cardiovascular morbidity is closely associated with serum lipid level. We aimed to investigate the effects of different aromatase inhibitors, including letrozole, anastrozole, and exemestane, on the lipid profile of eastern Chinese breast cancer patients. We evaluated a retrospective cohort of eastern Chinese postmenopausal women with early-stage breast cancer who received aromatase inhibitors. A total of 116 postmenopausal women with early-stage breast cancer without prior cardiovascular disease were included. Lipid changes at 3, 6, 12, and 24 months were compared across the endocrine therapy categories. Our data demonstrated that exemestane treatment significantly decreased triglyceride level compared with letrozole after 24 months. However, the aromatase inhibitors had almost equivalent impacts on high-density liportein cholesterol, low-density lipoprotein cholesterol, and triglyceride after long-term aromatase inhibitor treatment. As a small-size retrospective study, our data do not support a judgment about whether one AI or another carries more or less risk in terms of lipid disorders in eastern Chinese breast cancer patients. The exact effects need further randomized, controlled trials to investigate.
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Fracture Repair in the Distal Radius in Postmenopausal Women: A Follow-Up 2 Years Postfracture Using HRpQCT.
de Jong, JJA, Heyer, FL, Arts, JJC, Poeze, M, Keszei, AP, Willems, PC, van Rietbergen, B, Geusens, PP, van den Bergh, JPW
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2016;(5):1114-22
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Fracture healing is characterized by an intense increase in modeling and remodeling of bone, which allows removal of the cast after a stable distal radius fracture within 3 to 5 weeks. However, at that time, bone strength has not recovered yet. We studied the changes in bone mineral density (BMD), microarchitecture, and bone stiffness after a distal radius fracture during a 2-year follow-up in comparison to the contralateral side and the association between the 2-year stiffness and baseline BMD, microarchitecture, and early changes in these parameters. The fractured side of 14 postmenopausal women (mean age 64 ± 8 years) with a conservatively treated distal radius fracture was scanned by high-resolution peripheral quantitative computed tomography (HRpQCT) at 1 to 2, 3 to 4, 6 to 8, and 12 weeks and 2 years postfracture. The same region contralaterally was scanned as well at the 2-year visit. BMD, microarchitecture, and stiffness parameters were determined and the fracture side was compared with the contralateral side using a linear mixed-effect model. Spearman's correlation was used to correlate the 2-year bone stiffness with baseline BMD, microarchitecture, and early 3-month changes in these parameters. Two years postfracture, cortical and trabecular thickness and torsional and bending stiffness were significantly higher at the fractured side compared with the nonfractured side (21%, 55%, 31%, and 29%, respectively, p < 0.05), whereas BMD was similar. Two-year torsional and bending stiffness correlated significantly with baseline BMD and cortical perimeter (|rho| ≥ 0.63, p < 0.016) but not with early changes in bone parameters. Using HRpQCT, this study illustrates that fracture healing is not completed by the time the cast is removed. We showed that from 6 weeks to 2 years postfracture, large changes occur in BMD, microarchitecture, and biomechanical parameters at the fractured side, which were fully recovered after 2 years in comparison to the nonfractured contralateral side. Interestingly, higher 2-year torsional and bending stiffness were associated with lower BMD and higher cortical perimeter at baseline. © 2015 American Society for Bone and Mineral Research.
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Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol.
Hodis, HN, Mack, WJ, Henderson, VW, Shoupe, D, Budoff, MJ, Hwang-Levine, J, Li, Y, Feng, M, Dustin, L, Kono, N, et al
The New England journal of medicine. 2016;(13):1221-31
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BACKGROUND Data suggest that estrogen-containing hormone therapy is associated with beneficial effects with regard to cardiovascular disease when the therapy is initiated temporally close to menopause but not when it is initiated later. However, the hypothesis that the cardiovascular effects of postmenopausal hormone therapy vary with the timing of therapy initiation (the hormone-timing hypothesis) has not been tested. METHODS A total of 643 healthy postmenopausal women were stratified according to time since menopause (<6 years [early postmenopause] or ≥10 years [late postmenopause]) and were randomly assigned to receive either oral 17β-estradiol (1 mg per day, plus progesterone [45 mg] vaginal gel administered sequentially [i.e., once daily for 10 days of each 30-day cycle] for women with a uterus) or placebo (plus sequential placebo vaginal gel for women with a uterus). The primary outcome was the rate of change in carotid-artery intima-media thickness (CIMT), which was measured every 6 months. Secondary outcomes included an assessment of coronary atherosclerosis by cardiac computed tomography (CT), which was performed when participants completed the randomly assigned regimen. RESULTS After a median of 5 years, the effect of estradiol, with or without progesterone, on CIMT progression differed between the early and late postmenopause strata (P=0.007 for the interaction). Among women who were less than 6 years past menopause at the time of randomization, the mean CIMT increased by 0.0078 mm per year in the placebo group versus 0.0044 mm per year in the estradiol group (P=0.008). Among women who were 10 or more years past menopause at the time of randomization, the rates of CIMT progression in the placebo and estradiol groups were similar (0.0088 and 0.0100 mm per year, respectively; P=0.29). CT measures of coronary-artery calcium, total stenosis, and plaque did not differ significantly between the placebo group and the estradiol group in either postmenopause stratum. CONCLUSIONS Oral estradiol therapy was associated with less progression of subclinical atherosclerosis (measured as CIMT) than was placebo when therapy was initiated within 6 years after menopause but not when it was initiated 10 or more years after menopause. Estradiol had no significant effect on cardiac CT measures of atherosclerosis in either postmenopause stratum. (Funded by the National Institute on Aging, National Institutes of Health; ELITE ClinicalTrials.gov number, NCT00114517.).
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Combined Training (Aerobic Plus Strength) Potentiates a Reduction in Body Fat but Demonstrates No Difference on the Lipid Profile in Postmenopausal Women When Compared With Aerobic Training With a Similar Training Load.
Rossi, FE, Fortaleza, AC, Neves, LM, Buonani, C, Picolo, MR, Diniz, TA, Kalva-Filho, CA, Papoti, M, Lira, FS, Freitas Junior, IF
Journal of strength and conditioning research. 2016;(1):226-34
Abstract
The aim of this study was to verify the effects of aerobic and combined training on the body composition and lipid profile of obese postmenopausal women and to analyze which of these models is more effective after equalizing the training load. Sixty-five postmenopausal women (age = 61.0 ± 6.3 years) were divided into 3 groups: aerobic training (AT, n = 15), combined training (CT [strength + aerobic], n = 32), and control group (CG, n = 18). Their body composition upper body fat (TF), fat mass (FM), percentage of FM, and fat-free mass (FFM) were estimated by dual-energy x-ray absorptiometry. The lipid profile, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein cholesterol were assessed. There was a statistically significant difference in the TF (AT = -4.4%, CT = -4.4%, and CG = 1.0%, p = 0.001) and FFM (AT = 1.7%, CT = 2.6%, and CG = -1.4%, p = 0.0001) between the experimental and the control groups. Regarding the percentage of body fat, there was a statistically significant difference only between the CT and CG groups (AT = -2.8%, CT = -3.9%, and CG = 0.31%; p = 0.004). When training loads were equalized, the aerobic and combined training decreased core fat and increased FFM, but only the combined training potentiated a reduction in percentage of body fat in obese postmenopausal women after the training program. High-density lipoprotein-c levels increased in the combined group, and the chol/HDL ratio (atherogenic index) decreased in the aerobic group; however, there were no significant differences between the intervention programs. Taken together, both the exercise training programs were effective for improving body composition and inducing an antiatherogenic status.
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Calcifediol improves lipid profile in osteopenicatorvastatin-treated postmenopausal women.
Catalano, A, Morabito, N, Basile, G, Cucinotta, D, Lasco, A
European journal of clinical investigation. 2015;(2):144-9
Abstract
BACKGROUND Low vitamin D serum levels have been associated with unfavourable lipid profile and poorer response to atorvastatin. Aims of this study were to test the effects of 25-hydroxyvitamin D3 (calcifediol) compared to parental vitamin D3 (cholecalciferol) supplementation on modifications of plasma 25(OH)D levels and lipid profile. MATERIALS AND METHODS Fifty-seven postmenopausal women (aged 59.03 ± 6.73 years) who were at low risk of fracture and with basal plasma 25(OH)D < 30 ng/mL were included if they were on atorvastatin treatment prescribed as appropriate. Recruited women were randomized to receive oral calcifediol or cholecalciferol, both at a dose of 140 μg according to a weekly regimen. RESULTS At baseline, 25(OH)D was negatively associated with BMI (r = -0.37; P = 0.004), total cholesterol (r = -0.31; P = 0.01) and LDL-C (r = -0.32; P = 0.02). After 24 weeks, 25(OH)D increased significantly in both groups (P < 0.001), although higher levels were obtained with calcifediol as compared with cholecalciferol (P < 0.001). Only in the calcifediol group, a significant reduction of LDL-C (P = 0.01) and an increase of HDL-C (P = 0.02) were obtained, even after adjustment for age, and baseline BMI, 25(OH)D and lipid levels (P < 0.05). The percentage changes in 25(OH)D levels were associated with the variations of LDL-C (r = -0.44; P = 0.01) and HDL-C levels (r = 0.30; P = 0.10). CONCLUSION Calcifediol administration in osteopenic and dyslipidemic postmenopausal women with low 25(OH)D improves lipid profile when added to an ongoing atorvastatin treatment.
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Circulating leptin, resistin, adiponectin, visfatin, adipsin and ghrelin levels and insulin resistance in postmenopausal women with and without the metabolic syndrome.
Chedraui, P, Pérez-López, FR, Escobar, GS, Palla, G, Montt-Guevara, M, Cecchi, E, Genazzani, AR, Simoncini, T, ,
Maturitas. 2014;(1):86-90
Abstract
OBJECTIVE To measure serum levels of adipsin, leptin, resistin, adiponectin, visfatin, ghrelin and insulin in postmenopausal women screened for the metabolic syndrome (METS). METHODS Serum of 100 postmenopausal women was analyzed using multiplex technology for the mentioned analytes. In addition, values for the homeostasis model assessment of insulin resistance (HOMA-IR) were calculated. Comparisons were performed in accordance to the presence or not of the METS and each of its components. Criteria of the American Heart Association were used to define the METS. RESULTS Age and time since menopause onset were similar in women with the METS (n=57) as compared to those without the syndrome (n=43). METS women displayed significantly higher levels of adipsin, leptin, resistin, insulin and HOMA-IR values and lower adiponectin levels. These differences were mainly observed among women with abdominal obesity, independent of fulfilling METS criteria or not. In this same sense, lower adiponectin levels significantly related to low HDL-C and high triglyceride levels; and higher insulin and HOMA-IR values related to high triglyceride and glucose levels, respectively. CONCLUSION In this sample, postmenopausal women with the METS displayed higher insulin and adipokine levels. These were mainly related to abdominal obesity and metabolic and lipid abnormalities. More research is warranted in this regard.