Isolated vitamin D supplementation improves the immune-inflammatory biomarkers in younger postmenopausal women: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The aim of this study was to evaluate the effect of vitamin D (VitD) supplementation on immune-inflammatory biomarkers in younger postmenopausal women. METHODS: In this double-blind, placebo-controlled trial, 160 postmenopausal women aged 50 to 65 years with amenorrhea ≥12 months were randomized into two groups: VitD group, oral supplementation with 1000 IU VitD3/day (n = 80) or placebo group (n = 80). The intervention time was 9 months, and the women were assessed at baseline and endpoint. Serum levels of interleukins (ILs)-1ß, IL-5, IL-6, IL-10, IL-12ρ70, IL-17α, tumor necrosis factor-alpha, and interferon-gamma were determined by immunoassay. Plasma concentrations of 25-hydroxyvitamin D [25(OH)D] were measured by high-performance liquid chromatography. Per-protocol analysis was adopted as the statistical method using a gamma distribution and repeated measures design, followed by Wald's multiple comparisons test. RESULTS: The two groups were similar at baseline in terms of clinical and laboratory parameters. After 9 months, there was a significant increase of 25(OH)D levels in the VitD group (+45.4%, P < 0.001) and a decrease (-18.5%, P = 0.049) in the placebo group. A significant decrease in IL-5, IL-12p70, IL-17α, tumor necrosis factor-alpha, and interferon-gamma levels was observed in the VitD group (P < 0.05). IL-5 and IL-6 levels were significantly lower in the VitD group compared to the placebo group (P < 0.05). There were no significant intervention effects on serum IL-1ß or IL-10 levels in either group (P > 0.05). CONCLUSIONS: In younger postmenopausal women, isolated supplementation with 1000 IU of VitD3 for 9 months was associated with a reduction in proinflammatory biomarkers.

Effect of isolated vitamin D supplementation on the rate of falls and postural balance in postmenopausal women fallers: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the effect of isolated vitamin D supplementation (VITD) on the rate of falls and postural balance in postmenopausal women fallers. METHODS: In this double-blind, placebo-controlled trial, 160 Brazilian younger postmenopausal women were randomized into two groups: VITD group, vitamin D3 supplementation 1,000 IU/day/orally (n = 80) and placebo group (n = 80). Women with amenorrhea at least 12 months, age 50 to 65 years, and a history of falls (previous 12 months) were included. Those with neurological or musculoskeletal disorders, vestibulopathies, drugs use that could affect balance and osteoporosis were excluded. The intervention time was 9 months. Postural balance was assessed by stabilometry (computerized force platform) and investigation on the occurrence/recurrence of falls was performed by interviews. The plasma concentration of 25-hydroxyvitamin D [25(OH)D] was measured by high-performance liquid chromatography. Statistical analysis was achieved by intention-to-treat, using analysis of variance, Student's t test, Tukey test, chi-square, and logistic regression. RESULTS: After 9 months, mean values of 25(OH)D increased from 15.0 ±â€Š7.5 ng/mL to 27.5 ±â€Š10.4 ng/mL (+45.4%) in the VITD group, and decreased from 16.9 ±â€Š6.7 ng/mL to 13.8 ±â€Š6.0 ng/mL (-18.5%) in the placebo group (P < 0.001). The occurrence of falls was higher in the placebo group (+46.3%) with an adjusted risk of 1.95 (95% confidence interval [CI] 1.23-3.08) times more likely to fall and 2.80 (95% CI 1.43-5.50) times higher for recurrent falls compared to the VITD group (P < 0.001). There was reduction in body sway by stabilometry, with lower amplitude of antero-posterior (-35.5%) and latero-lateral (-37.0%) oscillation, only in the VITD group (P < 0.001). CONCLUSIONS: In Brazilian postmenopausal women fallers, isolated vitamin D supplementation for 9 months resulted in a lower incidence of falls and improvement in postural balance.

Avaliação dos fatores de risco de quedas em mulheres na pós-menopausa inicial / Evaluation of risk factors of falls in early postmenopausal Women

OBJETIVO: Foi avaliar a frequência e os fatores de risco de quedas em mulheres na pós-menopausa. MÉTODOS: Estudo clínico, transversal, envolvendo 358 mulheres (idade entre 45 e 65 anos e amenorreia >12 meses) com tempo de pós-menopausa <10 anos. Os critérios de exclusão foram: doença neurológica ou músculo esquelético, vestibulopatias, hipertensão arterial não controlada, hipotensão postural, déficit visual sem correção, uso de medicamentos (sedativos e hipnóticos). A queda foi definida como mudança de posição inesperada, não intencional, que faz com que o indivíduo permaneça em nível inferior à posição inicial. Foram analisados o histórico de quedas (últimos 24 meses) e as características clínicas, antropométricas (índice de massa corpórea (IMC) e circunferência da cintura (CC)) e densidade mineral óssea. Na comparação segundo grupo de mulheres com e sem histórico de queda, foi empregado o Teste do Qui-quadrado ou Exato de Fisher e regressão logística com cálculo do odds ratio (OR). RESULTADOS: Entre as mulheres incluídas, 48,0% (172/358) referiram queda, com fratura em 17,4% (30/172). A queda ocorreu dentro de casa em 58,7% (101/172). A média de idade foi 55,7±6,5 anos, tempo de menopausa de 5,8±3,5anos, IMC 28,3±4,6 kg/m² e CC 89,0±11,4 cm. Foi observada maior frequência de tabagismo e diabetes entre as mulheres com histórico de quedas quando comparadas àquelas sem queda, de 25,6 versus 16,1% e 12,8 versus 5,9%, respectivamente (p<0,05). Na análise multivariada em função das variáveis clínicas influentes, o risco de queda aumentou com o tabagismo atual (OR 1,93; IC95% 1,01-3,71). Demais variáveis clínicas e antropométricas não influenciaram no risco de queda. CONCLUSÕES: Em mulheres na pós-menopausa inicial houve expressiva frequência de quedas. O tabagismo foi indicador clínico de risco para queda. Com o reconhecimento de fatores determinantes para queda, medidas preventivas são importantes, como a orientação de abolir o tabagismo.

PURPOSE: It was to evaluate the frequency and the risk factors of falls in early postmenopausal women. METHODS: A cross-sectional study was conducted on 358 women (age: 45-65 years and amenorrhea >12 months) with time since menopause <10 years. Exclusion criteria were: neurological or musculoskeletal disorders, vestibulopathies, uncorrected visual deficit, uncontrolled hypertension and postural hypotension, or drug use (sedative and hypnotic agents). A fall was identified as an unexpected unintentional change in position which causes an individual to remain in a lower level in relation to the initial position. The history of self-reported falls during the previous 24 months, and clinical and anthropometric data (body mass index (BMI) and waist circumference (WC)) and bone densitometric measures were analyzed. For statistical analysis, c² trend test and the logistic regression method (odds ratio (OR)) were used for the comparison between groups of women with and without falls. RESULTS: Of the 358 women, 48.0% (172/358) had a history of falls and 17.4% (30/172) had fractures. The fall occurred indoors (at home) in 58.7% (101/172). The mean age was 53.7±6.5 years, time since menopause 5.8±3.5 years, BMI 28.3±4.6 kg/m² and WC 89.0±11.4 cm. There were differences as the occurrence of smoking and diabetes, with greater frequency among fallers vs. non-fallers, 25.6 versus 16.1% and 12.8 versus 5.9%, respectively (p<0.05). By evaluating the risk of falls in the presence of influential variables, it was observed that risk increased with current smoking status (OR 1.93; 95%CI 1.01-3.71), whereas other clinical and anthropometric variables did not influence this risk. CONCLUSIONS: In early postmenopausal women there was higher frequency of falls. Current smoking was clinical indicators of risk for falls. With the recognition of factors for falling, preventive measures become important, as the orientation of abolishing smoking.

[Evaluation of risk factors of falls in early postmenopausal women]. / Avaliação dos fatores de risco de quedas em mulheres na pós-menopausa inicial.

PURPOSE: It was to evaluate the frequency and the risk factors of falls in early postmenopausal women. METHODS: A cross-sectional study was conducted on 358 women (age: 45-65 years and amenorrhea >12 months) with time since menopause <10 years. Exclusion criteria were: neurological or musculoskeletal disorders, vestibulopathies, uncorrected visual deficit, uncontrolled hypertension and postural hypotension, or drug use (sedative and hypnotic agents). A fall was identified as an unexpected unintentional change in position which causes an individual to remain in a lower level in relation to the initial position. The history of self-reported falls during the previous 24 months, and clinical and anthropometric data (body mass index (BMI) and waist circumference (WC)) and bone densitometric measures were analyzed. For statistical analysis, c² trend test and the logistic regression method (odds ratio (OR)) were used for the comparison between groups of women with and without falls. RESULTS: Of the 358 women, 48.0% (172/358) had a history of falls and 17.4% (30/172) had fractures. The fall occurred indoors (at home) in 58.7% (101/172). The mean age was 53.7 ± 6.5 years, time since menopause 5.8 ± 3.5 years, BMI 28.3 ± 4.6 kg/m² and WC 89.0 ± 11.4 cm. There were differences as the occurrence of smoking and diabetes, with greater frequency among fallers vs. non-fallers, 25.6 versus 16.1% and 12.8 versus 5.9%, respectively (p<0.05). By evaluating the risk of falls in the presence of influential variables, it was observed that risk increased with current smoking status (OR 1.93; 95%CI 1.01-3.71), whereas other clinical and anthropometric variables did not influence this risk. CONCLUSIONS: In early postmenopausal women there was higher frequency of falls. Current smoking was clinical indicators of risk for falls. With the recognition of factors for falling, preventive measures become important, as the orientation of abolishing smoking.

Effect of hormone therapy on postural balance in postmenopausal women.

OBJECTIVE: The aim of this study was to analyze the effects of hormone therapy (HT) on postural balance in postmenopausal women and its association with risk of falls. METHODS: In this cross-sectional study, a total of 225 Brazilian postmenopausal women aged 45 to 75 years were included and divided into two groups: HT users (n = 102) and nonusers (n = 123). HT users were women who had continuously taken HT throughout the preceding 6 months, whereas nonusers received no such therapy during the same period. Women with amenorrhea for more than 12 months and aged 45 years or older were included. Those with neurological or musculoskeletal disorders, vestibulopathies, uncorrected visual deficit, or drug use that could affect balance were excluded. Histories of falls (previous 24 mo) as well as clinical and anthropometric characteristics were analyzed. Postural balance was assessed through stabilometry (computerized force platform), Romberg test, and crouching test. Statistical analysis included the median test, χ test, Spearman correlation coefficient, and logistic regression method (odds ratio). RESULTS: Women users of HT were younger (53.0 vs 57.0 y) and with a shorter time since menopause (5.5 vs 10.0 y) than nonusers (P < 0.05). No anthropometric differences were observed. The number of women who had experienced falls was significantly lower among HT users than nonusers: 51 vs 88 falls, respectively (P < 0.05), and presented an adjusted risk of falls of 0.49 (95% CI, 0.27-0.88) times lower than the nonusers group. For the stabilometric parameters, HT users showed significantly lower amplitude in body oscillation (latero-lateral and antero-posterior) and a smaller oscillation area compared with nonusers (P < 0.05). There was no significant correlation between the Romberg test and fall rate (P > 0.05). In the crouching test, 47.1% of the participants showed an adequate level of muscle strength in lower limbs without differences between the groups (P > 0.05). CONCLUSIONS: Postmenopausal women using HT showed lower frequency of falls and a better performance in stabilometric parameters than did nonusers.

Evaluation of postural balance in postmenopausal women and its relationship with bone mineral density--a cross sectional study.

BACKGROUND: Low bone mineral density (BMD) and falls are common problems encountered in the postmenopausal women. The purpose was to evaluate the association between postural balance and BMD in postmenopausal women and its relation to risk for falls. METHODS: In this cross-sectional study, 225 women in amenorrhea > 12 months and age ≥ 45 years were included and divided, according to BMD, in T-score values > -2.0 SD (n = 140) and ≤ -2 SD (n = 85). Those with neurological or musculoskeletal disorders, history of vestibulopathies, uncorrected visual deficit or drug use that could affect balance were excluded. History of falls (last 24 months), clinical and anthropometric characteristics were evaluated. Postural balance was assessed by stabilometry (force platform). For statistical analysis were used Wilcoxon's Test, Chi-Square Test and logistic regression method for fall risk (Odds Ratio-OR). RESULTS: Patients with BMD > -2.0 SD were younger, with shorter time since menopause, and showed higher BMI as compared to those with low BMD (≤ -2 SD) (p < 0.05). It was observed that 57.8% of the participants reported fall episodes without significant difference distribution between the groups (p = 0.055). No differences were found from the comparison between the groups (p > 0.05) for stabilometric parameters. Risk for falls increased with age (OR 1.07; CI 95% 1.01-1.13), current smoking (OR 2.19; CI 95% 1.22-3.21) and corrected visual deficit (OR 9.06; CI 95% 1.14-4.09). In contrast, hormone therapy (HT) use was significantly associated with reduced risk for falls (OR 0.48; CI 95% 0.26-0.88). CONCLUSIONS: In postmenopausal women, BMD did not show association with postural balance or risk for falls. Age, smoking and corrected visual deficit were clinical indicators of risk for falls whereas HT use showed to be a protective factor.

[Risk factors for osteoporosis in postmenopausal women from southeast Brazilian]. / Fatores de risco para osteoporose em mulheres na pós-menopausa do sudeste brasileiro.

PURPOSE: To evaluate bone mineral density (BMD) and their risk factors associated with postmenopausal osteoporosis. METHODS: A cross-sectional clinical study was performed on 431 women (aged 40-75 years). INCLUSION CRITERIA: amenorrhea > 12 months and age > 45 years or, bilateral oophorectomy > 40 years with BMD values (T-score of lumbar spine/femur neck) by DXA of the last 12 months. Risk factors evaluated: age, age and time of menopause, smoking, physical activity (30 min/5 times/week), rheumatoid arthritis (RA), use of corticotherapy and hormone therapy (HT), previous fracture, maternal hip fracture and body mass index (BMI = weight/height²). The χ2 test and the logistic regression method (Odds Ratio--OR) were used to determine osteoporosis risk. RESULTS: According to WHO criteria, 106 (24.6%) women showed osteoporosis (T-score < -2.5 DP), 188 (43.6%) osteopenia (-1.0/-2.4 DP), and 137 (31.8%) were normal (> -1.0 DP). Osteoporosis was detected in 12% of women aged 40-49 years, in 21.8% of women aged 50-59 years and in 45.7% of women aged > 60 years (p < 0.001). Osteoporosis occurred in 11.8% of women with a menopause period < 5 years, in 29.4% with a menopause period from 6 to 10 years, and in 41% of women with a menopause period > 10 years (p < 0.001). Of the women with early menopause, 80% showed osteopenia/osteoporosis (p = 0.03), and of those with BMI < 20 kg/m², 50% were osteoporotic (p < 0.001). The risk for osteoporosis detection increased with age (OR = 1.1; CI 95% = 1.0-1.1), time of menopause (OR = 1.1; CI 95% = 1.0-1.1), smoking (OR = 1.9; CI 95% = 1.2-3.2), RA (OR = 3.6; CI 95% = 1.3-9.6) and maternal fracture history (OR = 2.1; CI 95% = 1.1-3.0) (p < 0.05). In contrast, HT use (OR = 0.3; 95% CI = 0.2-0.6) and high BMI (OR = 0.9; 95% CI = 0.8-0.9) reduced the risk (p < 0.05). CONCLUSION: In postmenopausal women, age, time of menopause, smoking and maternal history of fracture were clinical indicators of risk for osteoporosis, whereas HT use and high BMI proved to be protective factors.

Fatores de risco para osteoporose em mulheres na pós-menopausa do sudeste brasileiro / Risk factors for osteoporosis in postmenopausal women from southeast Brazilian

OBJETIVO: Avaliar a densidade mineral óssea (DMO) e os fatores de risco associados à osteoporose na pós-menopausa. MÉTODOS: Estudo clínico transversal com 431 mulheres (idade 40 - 75 anos). Foram incluídas mulheres com: amenorréia >12 meses e idade >45 anos ou, ooforectomia bilateral >40 anos, com DMO (escore T de coluna lombar/colo de fêmur) pelo DEXA dos últimos 12 meses. Fatores de risco avaliados: idade, idade e tempo de menopausa, tabagismo, atividade física (30 min/5 vezes/ semana), artrite reumatoide (AR), uso de corticoterapia e de terapia hormonal (TH), fratura prévia, fratura materna de quadril e índice de massa corpórea (IMC=peso/altura²). Foram empregodos teste do χ² e método de regressão logística no risco (Odds Ratio - OR) para osteoporose. RESULTADOS: Pelos critérios da Organização Mundial da Saúde, 106 (24,6 por cento) mulheres apresentavam osteoporose (escore T <-2,5DP), 188 (43,6 por cento) osteopenia (-1,0/-2,4DP) e 137 (31,8 por cento) eram normais (>-1,0DP). Foi detectada osteoporose em 12 por cento das mulheres com idade entre 40 e 49anos, em 21,8 por cento no grupo de 50 a 59 anos e 45,7 por cento nas mulheres com idade >60anos (p<0,001). Osteoporose ocorreu em 11,8 por cento com tempo de menopausa <5 anos, 29,4 por cento de 6 - 10 anos, e 41 por cento >10anos (p<0,001). Naquelas com idade da menopausa <40 anos, 80 por cento apresentaram osteopenia/osteoporose (p=0,03) e com IMC<20kg/m², 50 por cento osteoporóticas (p<0,001). O risco de detectar osteoporose aumentou com a idade (OR=1,1; IC95 por cento=1,0-1,1), tempo de menopausa (OR=1,0; IC95 por cento=1,0-1,1), tabagismo atual (OR=2,1; IC95 por cento=1,2-3,8), AR (OR=3,6; IC95 por cento=1,3-9,6) e história materna de fratura de quadril (OR=2,1; IC95 por cento=1,1-3,0) (p<0,05). Contrariamente, o uso de TH (OR=0,49; IC95 por cento=0,3-0,9) e elevado IMC (OR=0,9; IC95 por cento=0,8-0,9) reduziram o risco de detecção da osteoporose (p<0,05)...

PURPOSE: To evaluate bone mineral density (BMD) and their risk factors associated with postmenopausal osteoporosis. METHODS: A cross-sectional clinical study was performed on 431 women (aged 40 - 75 years). Inclusion criteria: amenorrhea >12 months and age >45 years or, bilateral oophorectomy >40 years with BMD values (T-score of lumbar spine/femur neck) by DXA of the last 12 months. Risk factors evaluated: age, age and time of menopause, smoking, physical activity (30 min/5 times/week), rheumatoid arthritis (RA), use of corticotherapy and hormone therapy (HT), previous fracture, maternal hip fracture and body mass index (BMI=weight/height²). The χ2 test and the logistic regression method (Odds Ratio - OR) were used to determine osteoporosis risk. RESULTS: According to WHO criteria, 106 (24.6 percent) women showed osteoporosis (T-score <-2.5 DP), 188 (43.6 percent) osteopenia (-1.0/-2.4 DP), and 137 (31.8 percent) were normal (>-1.0 DP). Osteoporosis was detected in 12 percent of women aged 40 - 49 years, in 21.8 percent of women aged 50 - 59 years and in 45.7 percent of women aged >60 years (p<0.001). Osteoporosis occurred in 11.8 percent of women with a menopause period <5 years, in 29.4 percent with a menopause period from 6 to 10 years, and in 41 percent of women with a menopause period >10 years (p<0.001). Of the women with early menopause, 80 percent showed osteopenia/osteoporosis (p=0.03), and of those with BMI <20 kg/m², 50 percent were osteoporotic (p<0.001). The risk for osteoporosis detection increased with age (OR=1.1; CI95 percent=1.0-1.1), time of menopause (OR=1.1; CI95 percent=1.0-1.1), smoking (OR=1.9; CI95 percent=1.2-3.2), RA (OR=3.6; CI95 percent=1.3-9.6) and maternal fracture history (OR=2.1; CI95 percent=1.1-3.0) (p<0.05). In contrast, HT use (OR=0.3; 95 percentCI=0.2-0.6) and high BMI (OR=0.9; 95 percentCI=0.8-0.9) reduced the risk (p<0.05)...