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Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial.
Havens, PL, Stephensen, CB, Van Loan, MD, Schuster, GU, Woodhouse, LR, Flynn, PM, Gordon, CM, Pan, CG, Rutledge, B, Harris, DR, et al
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2018;(2):220-228
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Abstract
BACKGROUND Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF. METHODS This was a randomized, double-blind, placebo-controlled trial of directly observed VITD3 vs placebo every 4 weeks for 48 weeks in youth aged 16-24 years with HIV, RNA load <200 copies/mL, taking TDF-containing combination antiretroviral therapy (TDF-cART) for ≥180 days. Participants (N = 214) received a daily multivitamin containing VITD3 400 IU and calcium 162 mg, plus monthly randomized VITD3 50000 IU (n = 109) or placebo (n = 105). Outcome was change from baseline to week 48 in lumbar spine BMD (LSBMD). Data presented are median (Q1, Q3). RESULTS Participants were aged 22.0 (21.0, 23.0) years, 84% were male, and 74% were black/African American. At baseline, 62% had 25-hydroxy vitamin D (25-OHD) <20 ng/mL. Multivitamin adherence was 49% (29%, 69%), and VITD3/placebo adherence 100% (100%, 100%). Vitamin D intake was 2020 (1914, 2168) and 284 (179, 394) IU/day, and serum 25-OHD concentration was 36.9 (30.5, 42.4) and 20.6 (14.4, 25.8) ng/mL at 48 weeks in VITD3 and placebo groups, respectively (P < .001). From baseline to week 48, LSBMD increased by 1.15% (-0.75% to 2.74%) in the VITD3 group (n = 99; P < .001) and 0.09% (-1.49% to 2.61%) in the placebo group (n = 89; P = .25), without between-group difference (P = .12). VITD3 group changes occurred with baseline 25-OHD <20 ng/mL (1.17% [-.82% to 2.90%]; P = .004) and ≥20 ng/mL (0.93% [-.26% to 2.15%]; P = .033). CONCLUSIONS For youth taking TDF-cART, LSBMD increased through 48 weeks with VITD3 plus multivitamin, but not with placebo plus multivitamin, independent of baseline vitamin D status. CLINICAL TRIALS REGISTRATION NCT01751646.
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[Effect of low-dose or standard-dose conjugated equine estrogen combined with different progesterone on bone density in menopause syndrome women].
Zuo, HL, Deng, Y, Wang, YF, Gao, LL, Xue, W, Zhu, SY, Ma, X, Sun, AJ
Zhonghua fu chan ke za zhi. 2018;(4):243-247
Abstract
Objective: To explore the effect of low-dose or standard-dose conjugated equine estrogen (CEE) combined with natural progesterone or dydrogesterone on bone density in menopause syndrome women. Methods: Totally 123 patients with menopause syndrome were recruited and randomly assigned to 3 treatment groups: group A (low-dose CEE+progesterone) , group B (standard-dose CEE+progesterone) , group C (standard-dose CEE+dydrogesterone) . Using continuous sequential regimen, the duration of intervention was 12 cycles. The bone mineral density of lumbar 2-4 and neck of femur, the bone metabolic markers, the level of FSH and estradiol were examined just before the drug administration and 12 months after the beginning of experiment. Results: There were 107 cases completed the one year trial. (1) Bone density: after 12 cycles of treatment, there was no significant change in bone density in group A (P>0.05) ; lumbar vertebrae of group B and C increased significantly, at 3.0% and 2.1%respectively (all P<0.05) . The bone density of left femoral neck of group C significantly increased by 2.9% (P=0.029) . There was no significant difference among the treatment groups at the beginning of experiment (P>0.05) . (2) Bone metabolic markers: after 12 cycles of treatment, the levels of calcium, phosphorus, alkaline phosphatase, Ca/Cr decreased significantly, the difference were statistically significant (all P<0.05) . There was no significant difference among the treatment groups at the beginning of experiment (P>0.05) . (3) Levels of FSH and estradiol: after 12 cycles of treatment, the levels of FSH in three groups were decreased significantly (all P<0.01) . The levels of estradiol in three groups were increased significantly (all P<0.01) . There was no significant difference among the treatment groups at the beginning of experiment (P>0.05) . Conclusions: Both low-dose and standard-dose menopause hormone therapy (MHT) could elevate the level of estradiol, reduce bone turnover, prevent bone loss of postmenopausal women effectively. The standard dose of MHT could also increase the density of vertebrae and femoral neck, and generate more clinical benefits.
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Effects of vitamin D supplementation on musculoskeletal health: a systematic review, meta-analysis, and trial sequential analysis.
Bolland, MJ, Grey, A, Avenell, A
The lancet. Diabetes & endocrinology. 2018;(11):847-858
Abstract
BACKGROUND The effects of vitamin D on fractures, falls, and bone mineral density are uncertain, particularly for high vitamin D doses. We aimed to determine the effect of vitamin D supplementation on fractures, falls, and bone density. METHODS In this systematic review, random-effects meta-analysis, and trial sequential analysis, we used findings from literature searches in previously published meta-analyses. We updated these findings by searching PubMed, Embase, and Cochrane Central on Sept 14, 2017, and Feb 26, 2018, using the search term "vitamin D" and additional keywords, without any language restrictions. We assessed randomised controlled trials of adults (>18 years) that compared vitamin D with untreated controls, placebo, or lower-dose vitamin D supplements. Trials with multiple interventions (eg, co-administered calcium and vitamin D) were eligible if the study groups differed only by use of vitamin D. We excluded trials of hydroxylated vitamin D analogues. Eligible studies included outcome data for total or hip fractures, falls, or bone mineral density measured at the lumbar spine, total hip, femoral neck, total body, or forearm. We extracted data about participant characteristics, study design, interventions, outcomes, funding sources, and conflicts of interest. The co-primary endpoints were participants with at least one fracture, at least one hip fracture, or at least one fall; we compared data for fractures and falls using relative risks with an intention-to-treat analysis using all available data. The secondary endpoints were the percentage change in bone mineral density from baseline at lumbar spine, total hip, femoral neck, total body, and forearm. FINDINGS We identified 81 randomised controlled trials (n=53 537 participants) that reported fracture (n=42), falls (n=37), or bone mineral density (n=41). In pooled analyses, vitamin D had no effect on total fracture (36 trials; n=44 790, relative risk 1·00, 95% CI 0·93-1·07), hip fracture (20 trials; n=36 655, 1·11, 0·97-1·26), or falls (37 trials; n=34 144, 0·97, 0·93-1·02). Results were similar in randomised controlled trials of high-dose versus low-dose vitamin D and in subgroup analyses of randomised controlled trials using doses greater than 800 IU per day. In pooled analyses, there were no clinically relevant between-group differences in bone mineral density at any site (range -0·16% to 0·76% over 1-5 years). For total fracture and falls, the effect estimate lay within the futility boundary for relative risks of 15%, 10%, 7·5%, and 5% (total fracture only), suggesting that vitamin D supplementation does not reduce fractures or falls by these amounts. For hip fracture, at a 15% relative risk, the effect estimate lay between the futility boundary and the inferior boundary, meaning there is reliable evidence that vitamin D supplementation does not reduce hip fractures by this amount, but uncertainty remains as to whether it might increase hip fractures. The effect estimate lay within the futility boundary at thresholds of 0·5% for total hip, forearm, and total body bone mineral density, and 1·0% for lumbar spine and femoral neck, providing reliable evidence that vitamin D does not alter these outcomes by these amounts. INTERPRETATION Our findings suggest that vitamin D supplementation does not prevent fractures or falls, or have clinically meaningful effects on bone mineral density. There were no differences between the effects of higher and lower doses of vitamin D. There is little justification to use vitamin D supplements to maintain or improve musculoskeletal health. This conclusion should be reflected in clinical guidelines. FUNDING Health Research Council of New Zealand.
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Vitamin C intake in relation to bone mineral density and risk of hip fracture and osteoporosis: a systematic review and meta-analysis of observational studies.
Malmir, H, Shab-Bidar, S, Djafarian, K
The British journal of nutrition. 2018;(8):847-858
Abstract
We aimed to systematically review available data on the association between vitamin C intake and bone mineral density (BMD), as well as risk of fractures and osteoporosis, and to summarise this information through a meta-analysis. Previous studies on vitamin C intake in relation to BMD and risk of fracture and osteoporosis were selected through searching PubMed, Scopus, ISI Web of Science and Google Scholar databases before February 2017, using MeSH and text words. To pool data, either a fixed-effects model or a random-effects model was used, and for assessing heterogeneity, Cochran's Q and I 2 tests were used. Subgroup analysis was applied to define possible sources of heterogeneity. Greater dietary vitamin C intake was positively associated with BMD at femoral neck (pooled r 0·18; 0·06, 0·30) and lumbar spine (pooled r 0·14; 95 % CI 0·06, 0·22); however, significant between-study heterogeneity was found at femoral neck: I 2=87·6 %, P heterogeneity<0·001. In addition, we found a non-significant association between dietary vitamin C intake and the risk of hip fracture (overall relative risk=0·74; 95 % CI 0·51, 1·08). Significant between-study heterogeneity was found (I 2=79·1 %, P heterogeneity<0·001), and subgroup analysis indicated that study design, sex and age were the main sources of heterogeneity. Greater dietary vitamin C intake was associated with a 33 % lower risk of osteoporosis (overall relative risk=0·67; 95 % CI 0·47, 0·94). Greater dietary vitamin C intake was associated with a lower risk of hip fracture and osteoporosis, as well as higher BMD, at femoral neck and lumbar spine.
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The Association of Dietary and Urinary Sodium With Bone Mineral Density and Risk of Osteoporosis: A Systematic Review and Meta-Analysis.
Fatahi, S, Namazi, N, Larijani, B, Azadbakht, L
Journal of the American College of Nutrition. 2018;(6):522-532
Abstract
OBJECTIVE Although some earlier studies have indicated an association between dietary/urinary sodium and bone mass density (BMD), bone mass content (BMC), and the risk of osteoporosis (OS), findings are still conflicting. The aim of this study was to summarize the relation of dietary/urinary sodium with BMD, BMC, and the risk of OS. METHODS We conducted a systematic search up to April 2017 in PubMed/MEDLINE, SCOPUS, and Web of Science to find relevant studies. Articles with cross-sectional and cohort designs in which odds ratios (ORs), correlations (r), or beta coefficients were reported for the association between dietary/urinary sodium and OS, BMD, or BMC were included. RESULTS Pooling 11 effect sizes with a total of 39,065 people showed that higher sodium consumption significantly increased the risk of OS (OR = 1.20; 95% confidence interval [CI], 1.02-1.41; p = 0.026), with high heterogeneity among studies (I2 = 68.0%; p = 0.001). Subgroup analyses showed significantly higher risk of OS in premenopausal women (OR = 1.31; 95% CI, 1.01-1.69; p = 0.036), in participants with a mean age older than 50 years (OR = 1.15; 95% CI, 1.04-1.28; p = 0.005), in dietary sodium intake subgroup (OR = 1.45; 95% CI, 1.19-1.77; p < 0.001), and in individuals with adjustment for energy (OR = 1.77; 95% CI, 1.38-2.27; p < 0.001). The correlation coefficients showed no significant association between urinary sodium and BMD (r = -0.46; 95% CI, -0.74 to -0.18; p = 0.02). CONCLUSIONS We found a positive association between sodium intake and the risk of OS, while no association was found with urinary sodium. Furthermore, there was no significant correlation between sodium intake and BMD. Due to high heterogeneity in this research, more studies are suggested.
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Adherence to Mediterranean diet in relation to bone mineral density and risk of fracture: a systematic review and meta-analysis of observational studies.
Malmir, H, Saneei, P, Larijani, B, Esmaillzadeh, A
European journal of nutrition. 2018;(6):2147-2160
Abstract
PURPOSE We aimed to systematically review available data on the association between adherence to MD and BMD as well as risk of fractures and to summarize this information through a meta-analysis. METHODS Previous studies in the field of adherence to MD in relation to BMD and risk of fracture were selected through searching PubMed, Scopus, ISI Web of Science and Google Scholar databases prior to June, 2016 using Mesh and non-Mesh relevant keywords. RESULTS In the meta-analysis of four effect sizes, obtained from three studies, we found that adherence to MD was associated with a 21% reduced risk of hip fracture (overall RR 0.79; 95% CIs 0.72-0.87). Adherence to MD was positively associated with lumber spine's (mean difference of BMD comparing highest and lowest categories of MD score 0.12; 95% CI 0.06-0.19 g/cm2), femoral neck (0.10; 0.06-0.15 g/cm2) and total hip (0.11; 0.09-0.14 g/cm2) BMD. Meta-regression of included observational studies revealed a significant inverse linear association between Mediterranean diet score and risk of hip fracture, such that one unit increase in the score of Mediterranean diet was associated with a reduction in the risk of hip fracture (RR 0.95, 95% CI 0.92-0.98 p = 0.01). CONCLUSION Adherence to MD was associated with a reduced risk of fracture as well as with a higher mean BMD.
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Clinical profile of juvenile primary hyperparathyroidism: a prospective study.
Saponaro, F, Marcocci, C, Cacciatore, F, Miccoli, M, Pardi, E, Borsari, S, Materazzi, G, Miccoli, P, Cetani, F
Endocrine. 2018;(2):344-352
Abstract
INTRODUCTION Juvenile primary hyperparathyroidism is uncommon and more symptomatic than the adult counterpart. The aim of this prospective monocentric study, conducted in a tertiary referral center, was to evaluate the clinical, biochemical, and densitometric data, and the outcome of a series of patients with juvenile primary hyperparathyroidism. MATERIAL AND METHODS The study group included 154 patients with sporadic and familial juvenile primary hyperparathyroidism, aged ≤40 years. Relative frequency of sporadic and familial forms, comparison of the clinical and biochemical characteristics, rate of cure after parathyroidectomy and the outcome of patients not undergoing surgery were evaluated. RESULTS Familial cases (n = 42) were younger, less frequently females, and had milder disease compared to sporadic cases (n = 112). No difference was observed in biochemical and densitometric parameters. Among patients undergoing parathyroidectomy (n = 116), familial cases had a higher rate of multigland disease and a higher persistence/relapse rate compared to sporadic cases (73 vs. 3.6% and 48.1 vs. 5.7%, respectively). Patients who did not undergo parathyroidectomy had stable clinical, biochemical, and densitometric parameters during follow-up (median 27 months). Using the cut-off age of 25 years, there was no difference in clinical, biochemical and densitometric parameters between younger and older patients, with the exception of parathyroid hormone and phosphate, which were significantly lower and higher, respectively, in patients <25 years. CONCLUSIONS In conclusion, this prospective study shows that juvenile primary hyperparathyroidism is frequently a sporadic disease, with no difference in the biochemical phenotype between sporadic and familial forms. Patients with familial juvenile primary hyperparathyroidism have a milder clinical phenotype and higher rate of persistence/recurrence after PTx than those with sporadic juvenile primary hyperparathyroidism.
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The effect of a high-impact jumping intervention on bone mass, bone stiffness and fitness parameters in adolescent athletes.
Vlachopoulos, D, Barker, AR, Ubago-Guisado, E, Williams, CA, Gracia-Marco, L
Archives of osteoporosis. 2018;(1):128
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Abstract
UNLABELLED This study demonstrates that a 9-month jumping intervention can improve bone mass gains and physical fitness performance in adolescent males participating in non-osteogenic sports, such as swimming and cycling. PURPOSE To examine the effect of a jumping intervention on bone mass, bone stiffness and fitness parameters in adolescents involved in different sports. METHODS Ninety-three adolescent male swimmers (SWI), footballers (FOO) and cyclists (CYC) were randomised to intervention (INT) and sport (INT-SWI = 19, INT-FOO = 15, INT-CYC = 14) or sport only (CON-SWI = 18, CON-FOO = 15, CON-CYC = 12) groups. The 9-month jumping intervention consisted of 3 levels (12 weeks each) of 20 repetitions per set of counter movement jumps (CMJ) using adjustable weight vests (level 1 = 20 CMJ jumps/set, 0 kg, 3 sets/day, 3 times/week; level 2 = 20 CMJ jumps/set, 2 kg, 4 sets/day, 3 times/week; level 3 = 20 CMJ jumps/set, 5 kg, 4 sets/day, 4 times/week). Total body bone mineral content (BMC) at total body less head (TBLH) was measured using dual-energy X-ray absorptiometry and bone stiffness using quantitative ultrasound. Fitness was assessed using the 20-m shuttle run (20mSRT), CMJ and standing long jump (SLJ) tests. RESULTS INT-SWI had significantly higher increase in BMC legs and bone stiffness compared to CON-SWI (4.2-12.7%). INT-CYC had significantly higher increase in BMC at TBLH and legs and bone stiffness compared to CON-CYC (5.0-12.3%). There were no significant differences between INT-FOO and CON-FOO in any bone outcomes (0.9-3.9%). The increase in CMJ performance was significantly higher in INT-SWI (3.1 cm) and INT-CYC (3.2 cm) compared to CON-SWI and CON-CYC groups, respectively. CONCLUSIONS A 9-month jumping intervention can improve bone mass, bone stiffness and muscular fitness in adolescent males participating in non-osteogenic sports, such as swimming and cycling. CLINICAL TRIAL REGISTRATION ISRCTN17982776.
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Skeletal Status, Body Composition, and Glycaemic Control in Adolescents with Type 1 Diabetes Mellitus.
Wierzbicka, E, Swiercz, A, Pludowski, P, Jaworski, M, Szalecki, M
Journal of diabetes research. 2018;:8121634
Abstract
BACKGROUND Disturbed bone turnover, osteoporosis, and increased fracture risk are late complications of insulin-dependent diabetes mellitus. Little is known about how far and to what extent can glycaemic control of type 1 diabetes mellitus (T1DM) prevent disturbances of bone health and body composition during the growth and maturation period. OBJECTIVE The aim of this cross-sectional study was to compare the skeletal status outcomes and body composition between patients stratified by glycaemic control (1-year HbA1c levels) into well- and poorly-controlled subgroups in a population of T1DM adolescents, that is, <8% and ≥8%, respectively. SUBJECTS AND METHODS Skeletal status and body composition were evaluated in 60 adolescents with T1DM (53.3% female; mean aged: 15.1 ± 1.9 years; disease duration: 5.1 ± 3.9 years) using dual energy X-ray absorptiometry (GE Prodigy). The results were compared to age- and sex-adjusted reference values for healthy controls. The calculated Z-scores of different metabolic control subgroups were compared. Clinical data was also assessed. RESULTS As evidenced by Z-scores, patients with T1DM revealed a significantly lower TBBMD (total body bone mineral density), TBBMC (total body bone mineral content), S24BMD (bone mineral density of lumbar spine L2-L4), and TBBMC/LBM ratio (total body bone mineral content/lean body mass), but higher FM (fat mass) and FM/LBM ratio (fat mass/lean body mass) values compared to an age- and sex-adjusted general population. The subset (43.3% patients) with poor metabolic control (HbA1c ≥ 8%) had lower TBBMD, TBBMC, and LBM compared to respective values noted in the HbA1c < 8% group, after adjusting for confounders (mean Z-scores: -0.74 vs. -0.10, p = 0.037; -0.67 vs. +0.01, p = 0.026; and -0.45 vs. +0.20, p = 0.043, respectively). Additionally, we found a significant difference in the TBBMC/LBM ratio (relative bone strength index) between the metabolic groups (-0.58 vs. -0.07; p = 0.021). A statistically significant negative correlation between 1-year HbA1c levels and Z-scores of TBBMD, TBBMC, and LBM was also observed. In patients with longer disease duration, a significant negative correlation was established only for TBBMD, after adjusting for confounders. The relationships between densitometric values and age at onset of T1DM and sex were not significant and showed no relation to any of the analysed parameters of the disease course. CONCLUSION Findings from this study of adolescents with T1DM indicate that the lower Z-scores of TBBMD, TBBMC, and LBM as well as the TBBMC/LBM ratio are associated with increased HbA1c levels. Their recognition can be crucial in directing strategies to optimise metabolic control and improve diabetes management for bone development and maintenance in adolescents with T1DM.
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Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture.
Donlon, CM, LeBoff, MS, Chou, SH, Cook, NR, Copeland, T, Buring, JE, Bubes, V, Kotler, G, Manson, JE
Contemporary clinical trials. 2018;:56-67
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Abstract
UNLABELLED Vitamin D supplements are often used to benefit skeletal health, although data on effects of daily high-dose vitamin D alone on bone density and structure are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, randomized, placebo-controlled trial testing effects of high-dose supplemental vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (FAs; 1 g/day) for the primary prevention of cancer and cardiovascular disease. The study has a mean treatment period of 5 years among 25,874 U.S. men ≥50 years and women ≥55 years old from all 50 states. The ancillary study, VITAL Effects on Bone Structure and Architecture, is testing effects of vitamin D3 and/or omega-3 FAs on musculoskeletal outcomes and body composition in a subcohort of 771 participants. At in-person visits at the Harvard Catalyst Clinical and Translational Science Center (CTSC), participants completed bone density/architecture, body composition, and physical performance assessments at baseline and two-year follow-up. Baseline characteristics were evenly distributed among treatment groups, suggesting that any uninvestigated confounders will be evenly distributed; sex differences were also analyzed. Future analyses of the two-year follow-up visits will elucidate whether daily high-dose, supplemental vitamin D3 and/or omega-3 FAs improve musculoskeletal outcomes, helping to advance clinical and public health recommendations. CLINICAL TRIAL REGISTRATION NUMBER NCT01747447.