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Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial.
Sales, LP, Pinto, AJ, Rodrigues, SF, Alvarenga, JC, Gonçalves, N, Sampaio-Barros, MM, Benatti, FB, Gualano, B, Rodrigues Pereira, RM
The journals of gerontology. Series A, Biological sciences and medical sciences. 2020;(5):931-938
Abstract
BACKGROUND Creatine supplementation could be a nonexpensive, safe, and effective dietary intervention to counteract bone loss. The aim of this study was to investigate whether long-term creatine supplementation can improve bone health in older, postmenopausal women. METHODS A double-blind, placebo-controlled, parallel-group, randomized trial was conducted between November 2011 and December 2017 in Sao Paulo, Brazil. Two hundred postmenopausal women with osteopenia were randomly allocated to receive either creatine monohydrate (3 g/d) or placebo for 2 years. At baseline and after 12 and 24 months, we assessed areal bone mineral density (aBMD; primary outcome), lean and fat mass (through dual X-ray absorptiometry), volumetric BMD and bone microarchitecture parameters, biochemical bone markers, physical function and strength, and the number of falls and fractures. Possible adverse effects were self-reported. RESULTS Lumbar spine (p < .001), femoral neck (p < .001), and total femur aBMD (p = .032) decreased across time; however, no interaction effect was observed (all p > .050). Bone markers, microarchitecture parameters, and the number of falls/fractures were not changed with creatine (all p > .050). Lean mass and appendicular skeletal muscle mass increased throughout the intervention (p < .001), with no additive effect of creatine (p = .731 and p = .397, respectively). Creatine did not affect health-related laboratory parameters. CONCLUSION Creatine supplementation more than 2 years did not improve bone health in older, postmenopausal women with osteopenia, nor did it affect lean mass or muscle function in this population. This refutes the long-lasting notion that this dietary supplement alone has osteogenic or anabolic properties in the long run. CLINICAL TRIAL REGISTRY Clinicaltrials.gov: NCT: 01472393.
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Fall Prevention and Anti-Osteoporosis in Osteopenia Patients of 80 Years of Age and Older: A Randomized Controlled Study.
Zhou, J, Liu, B, Qin, MZ, Liu, JP
Orthopaedic surgery. 2020;(3):890-899
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Abstract
UNLABELLED To evaluate the effects of two fall-prevention and anti-osteoporotic protocols in elderly patients with osteopenia (OPA). METHODS The present randomized controlled study included patients with OPA (n =123). The age of these patients was ≥80 years old, with the mean age of 83.54 ± 2.99 years, and the male-to-female ratio was 2.97:1.00. Fall-prevention guidance was given to all patients. Patients in the experiment group (n = 62) orally received 600 mg/d of calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate, while patients in the control group (n = 61) orally received 600 mg/d of calcium carbonate and 0.5 μg/d of alfacalcidol for 18 months. The grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density were measured, and the Timed Up and Go (TUG) test and the chair rising test (CRT) were performed. Falls, fragility fractures, medication compliance, and side effects of the drugs were recorded. RESULTS The serum levels of bone turnover markers (type I procollagen amino-terminal peptide [P1NP], type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC]) decreased, while the bone mineral density of the lumbar spine and bilateral femoral neck increased after treatment in the experiment group (P < 0.05, P < 0.01). The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01). After treatment, the proportion of patients with increased hip T scores in the experiment group (66.1%, 41/62) was significantly higher than the proportion (35.0%, 21/60) in the control group (P = 0.001). The incidence of fall decreased in both groups after treatment compared to that before treatment (54.8% vs 33.9% and 54.1% vs 36.7%, respectively; P < 0.05). The incidence of fragility fractures was lower in the experiment group than the control group (8.1% vs 20.0%, P = 0.057). During the intervention period, the incidence of fragility fractures in patients who did not fall (3.8%, 3/79) was significantly lower than that in patients who fell (32.6%, 14/43) (P = 0.000). The risk of fragility fractures was significantly lower in patients who did not fall compared to patients who fell (relative risk: 0.117, 95% confidence interval: 0.035-0.384). CONCLUSION The combination of alendronate sodium with alfacalcidol and calcium can significantly improve the bone mineral density of the lumbar spine and femoral neck. For older patients with OPA, subjectively paying attention to avoiding falls can significantly reduce the risk of fragility fractures.
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Anti-fracture efficacy of zoledronate in subgroups of osteopenic postmenopausal women: secondary analysis of a randomized controlled trial.
Reid, IR, Horne, AM, Mihov, B, Stewart, A, Garratt, E, Wiessing, KR, Bolland, MJ, Bastin, S, Gamble, GD
Journal of internal medicine. 2019;(2):221-229
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Abstract
BACKGROUND We recently reported that the administration of zoledronate every 18 months to osteopenic older women reduces the incidence of fractures. OBJECTIVE Here, we present a more detailed analysis of that trial to determine whether baseline clinical characteristics impact on the anti-fracture efficacy of this intervention. METHODS This is a prospective, randomized, placebo-controlled, double-blind trial in osteopenic postmenopausal women aged ≥ 65 years, to determine the anti-fracture efficacy of zoledronate. 2000 women were recruited using electoral rolls and randomized to receive 4 infusions of either zoledronate 5 mg or normal saline, at 18-month intervals. Each participant was followed for 6 years. Calcium supplements were not supplied. RESULTS Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001). There were no significant interactions between baseline variables (age, anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk) and the treatment effect. In particular, the reduction in fractures appeared to be independent of baseline fracture risk, and numbers needed to treat (NNT) to prevent one woman fracturing were not significantly different across baseline fracture risk tertiles. CONCLUSIONS The present analyses indicate that the decrease in fracture numbers is broadly consistent across this cohort. The lack of relationship between NNTs and baseline fracture risk calls into question the need for BMD measurement and precise fracture risk assessment before initiating treatment in older postmenopausal women.
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The Effect of Dried Beancurd on Bone Mineral Density in Postmenopausal Chinese Women: A 2-Year Randomized Controlled Trial.
Li, L, Sun, M, Sun, J, Kong, H, Zhong, W, Wang, H
Calcified tissue international. 2019;(6):573-581
Abstract
Soy foods contain several components such as isoflavones, calcium and protein that potentially modulate bone turnover and increase bone mineral density (BMD) in postmenopausal women. The study is to evaluate the effect of dried beancurd supplementation on skeletal health in postmenopausal Chinese women. Three hundred postmenopausal women aged 50-65 years were assigned into two groups, receiving 100 g dried beancurd or rice cake a day for 2 years. BMD at the lumbar spine and right proximal femur were measured with a dual-energy X-ray absorptiometry. The bone turnover biomarkers of serum alkaline phosphatase (ALP), bone Gla protein (BGP) and urinary N-telopeptide cross-links of collagen normalized for creatinine (NTX/CRT) were also determined. Serum isoflavone concentration was analyzed by high performance liquid chromatography. The 2-year dried beancurd supplementation generated a significant increase in lumbar spine BMD. An obvious decrease was found in urinary NTX/CRT, and a significant increase was detected in serum isoflavone concentration. The dried beancurd supplementation had no effect on changes of right proximal femur BMD and concentrations of serum ALP and BGP. Daily supplementation of dried beancurd could increase BMD of lumbar spine, but does not slow bone loss at right proximal femur in postmenopausal Chinese women.
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Exercise Mitigates Bone Loss in Women With Severe Obesity After Roux-en-Y Gastric Bypass: A Randomized Controlled Trial.
Murai, IH, Roschel, H, Dantas, WS, Gil, S, Merege-Filho, C, de Cleva, R, de Sá-Pinto, AL, Lima, F, Santo, MA, Benatti, FB, et al
The Journal of clinical endocrinology and metabolism. 2019;(10):4639-4650
Abstract
CONTEXT Bone loss after bariatric surgery potentially could be mitigated by exercise. OBJECTIVE To investigate the role of exercise training (ET) in attenuating bariatric surgery-induced bone loss. DESIGN Randomized, controlled trial. SETTING Referral center for bariatric surgery. PATIENTS Seventy women with severe obesity, aged 25 to 55 years, who underwent Roux-en-Y gastric bypass (RYGB). INTERVENTION Supervised, 6-month, ET program after RYGB vs. standard of care (RYGB only). OUTCOMES Areal bone mineral density (aBMD) was the primary outcome. Bone microarchitecture, bone turnover, and biochemical markers were secondary outcomes. RESULTS Surgery significantly decreased femoral neck, total hip, distal radius, and whole body aBMD (P < 0.001); and increased bone turnover markers, including collagen type I C-telopeptide (CTX), procollagen type I N-propeptide (P1NP), sclerostin, and osteopontin (P < 0.05). Compared with RYGB only, exercise mitigated the percent loss of aBMD at femoral neck [estimated mean difference (EMD), -2.91%; P = 0.007;], total hip (EMD, -2.26%; P = 0.009), distal radius (EMD, -1.87%; P = 0.038), and cortical volumetric bone mineral density at distal radius (EMD, -2.09%; P = 0.024). Exercise also attenuated CTX (EMD, -0.20 ng/mL; P = 0.002), P1NP (EMD, -17.59 ng/mL; P = 0.024), and sclerostin levels (EMD, -610 pg/mL; P = 0.046) in comparison with RYGB. Exercise did not affect biochemical markers (e.g., 25(OH)D, calcium, intact PTH, phosphorus, and magnesium). CONCLUSION Exercise mitigated bariatric surgery-induced bone loss, possibly through mechanisms involving suppression in bone turnover and sclerostin. Exercise should be incorporated in postsurgery care to preserve bone mass.
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Assessing the Effectiveness of Panchatikta Ghrita, a Classical Ayurvedic Formulation as Add-on Therapy to Vitamin D3 and Calcium Supplements in Patients with Osteopenia: A Randomized, Open-Labeled, Comparative, Controlled Clinical Study.
Munshi, RP, Kumbhar, DA, Panchal, FH, Varthakavi, P
Journal of alternative and complementary medicine (New York, N.Y.). 2019;(10):1044-1053
Abstract
Objectives: To assess the change in the bone mineral density (BMD) score, bone-specific biomarkers (serum vitamin D3, tartrate-resistant acid phosphatase 5b [TRAP-5b], and osteocalcin), quality of life, Ayurvedic symptoms (Asthikshaya Lakshanas), and fracture risk assessment tool (FRAX) scores following treatment with Panchatikta Ghrita (PG), a classical herbal formulation as add-on therapy to calcium and vitamin D3 supplements. Study design: Randomized, open-labeled, comparative, controlled clinical study. Location: TN Medical College and BYL Nair Hospital, Mumbai, India. Study participants: Eighty adult patients, aged between 40 and 75 years, diagnosed to have osteopenia (BMD T-score between -1 and -2.5 in at least two of the three joints tested-lumbar spine L1-L4, left femur-neck, left forearm-radius total). Study intervention: Treatment group received two tablespoons of PG (10 mL in lukewarm milk) along with calcium and vitamin D3 supplements twice a day, whereas control group received only calcium and vitamin D3 supplements twice a day for a period of 12 months. Outcome measures: BMD, bone-specific biomarkers (vitamin D3, TRAP-5b, and osteocalcin), quality of life, Ayurvedic symptoms, and FRAX scores were evaluated before and at 6 and 12 months. Results: Eighty patients were enrolled; of which, 65 patients completed the study while 15 patients dropped out. Improvement in the BMD scores was observed at 6 and 12 months with the maximum benefit in the lumbar spine region. Significant improvement in the bone-specific biomarkers, namely serum vitamin D3 (p < 0.001), osteocalcin (p < 0.001), and TRAP-5b (p < 0.05), was observed in the PG-treated group compared with the standard treatment group. Improvement in the quality of life, Ayurvedic symptoms scores, and risk reduction in FRAX scores of major osteoporotic fracture risk and hip fracture risk was greater with PG, although not statistically significant. Conclusions: The study findings demonstrate that PG slows down the bone degeneration processes by its stabilizing effect on the bone-specific biomarkers, indicating its potential usefulness as preventive therapy in osteopenia. The positive improvement noted in this study needs to be confirmed in studies with a larger sample size and longer duration.
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High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial.
Watson, SL, Weeks, BK, Weis, LJ, Harding, AT, Horan, SA, Beck, BR
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2018;(2):211-220
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Optimal osteogenic mechanical loading requires the application of high-magnitude strains at high rates. High-intensity resistance and impact training (HiRIT) applies such loads but is not traditionally recommended for individuals with osteoporosis because of a perceived high risk of fracture. The purpose of the LIFTMOR trial was to determine the efficacy and to monitor adverse events of HiRIT to reduce parameters of risk for fracture in postmenopausal women with low bone mass. Postmenopausal women with low bone mass (T-score < -1.0, screened for conditions and medications that influence bone and physical function) were recruited and randomized to either 8 months of twice-weekly, 30-minute, supervised HiRIT (5 sets of 5 repetitions, >85% 1 repetition maximum) or a home-based, low-intensity exercise program (CON). Pre- and post-intervention testing included lumbar spine and proximal femur bone mineral density (BMD) and measures of functional performance (timed up-and-go, functional reach, 5 times sit-to-stand, back and leg strength). A total of 101 women (aged 65 ± 5 years, 161.8 ± 5.9 cm, 63.1 ± 10.4 kg) participated in the trial. HiRIT (n = 49) effects were superior to CON (n = 52) for lumbar spine (LS) BMD (2.9 ± 2.8% versus -1.2 ± 2.8%, p < 0.001), femoral neck (FN) BMD (0.3 ± 2.6% versus -1.9 ± 2.6%, p = 0.004), FN cortical thickness (13.6 ± 16.6% versus 6.3 ± 16.6%, p = 0.014), height (0.2 ± 0.5 cm versus -0.2 ± 0.5 cm, p = 0.004), and all functional performance measures (p < 0.001). Compliance was high (HiRIT 92 ± 11%; CON 85 ± 24%) in both groups, with only one adverse event reported (HiRIT: minor lower back spasm, 2/70 missed training sessions). Our novel, brief HiRIT program enhances indices of bone strength and functional performance in postmenopausal women with low bone mass. Contrary to current opinion, HiRIT was efficacious and induced no adverse events under highly supervised conditions for our sample of otherwise healthy postmenopausal women with low to very low bone mass. © 2017 American Society for Bone and Mineral Research.
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Comparative Effects of Cholecalciferol and Calcitriol on Circulating Markers of CKD Mineral Bone Disorder: A Randomized Clinical Trial.
Zelnick, LR, de Boer, IH, Kestenbaum, BR, Chonchol, M, Kendrick, J
Clinical journal of the American Society of Nephrology : CJASN. 2018;(6):927-928
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Fracture Prevention with Zoledronate in Older Women with Osteopenia.
Reid, IR, Horne, AM, Mihov, B, Stewart, A, Garratt, E, Wong, S, Wiessing, KR, Bolland, MJ, Bastin, S, Gamble, GD
The New England journal of medicine. 2018;(25):2407-2416
Abstract
BACKGROUND Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with osteopenia is unknown. Most fractures in postmenopausal women occur in those with osteopenia, so therapies that are effective in women with osteopenia are needed. METHODS We conducted a 6-year, double-blind trial involving 2000 women with osteopenia (defined by a T score of -1.0 to -2.5 at either the total hip or the femoral neck on either side) who were 65 years of age or older. Participants were randomly assigned to receive four infusions of either zoledronate at a dose of 5 mg (zoledronate group) or normal saline (placebo group) at 18-month intervals. A dietary calcium intake of 1 g per day was advised, but calcium supplements were not provided. Participants who were not already taking vitamin D supplements received cholecalciferol before the trial began (a single dose of 2.5 mg) and during the trial (1.25 mg per month). The primary end point was the time to first occurrence of a nonvertebral or vertebral fragility fracture. RESULTS At baseline, the mean (±SD) age was 71±5 years, the T score at the femoral neck was -1.6±0.5, and the median 10-year risk of hip fracture was 2.3%. A fragility fracture occurred in 190 women in the placebo group and in 122 women in the zoledronate group (hazard ratio with zoledronate, 0.63; 95% confidence interval, 0.50 to 0.79; P<0.001). The number of women that would need to be treated to prevent the occurrence of a fracture in 1 woman was 15. As compared with the placebo group, women who received zoledronate had a lower risk of nonvertebral fragility fractures (hazard ratio, 0.66; P=0.001), symptomatic fractures (hazard ratio, 0.73; P=0.003), vertebral fractures (odds ratio, 0.45; P=0.002), and height loss (P<0.001). CONCLUSIONS The risk of nonvertebral or vertebral fragility fractures was significantly lower in women with osteopenia who received zoledronate than in women who received placebo. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12609000593235 .).
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Magnetic Resonance Spectroscopy for Evaluating the Effect of Pulsed Electromagnetic Fields on Marrow Adiposity in Postmenopausal Women With Osteopenia.
Li, S, Jiang, H, Wang, B, Gu, M, Bi, X, Yin, Y, Wang, Y
Journal of computer assisted tomography. 2018;(5):792-797
Abstract
OBJECTIVE Pulsed electromagnetic fields (PEMFs) could promote osteogenic differentiation and suppress adipogenic differentiation in bone mesenchymal stem cells ex vivo. However, data on the effect of PEMF on marrow adiposity in humans remain elusive. We aimed to determine the in vivo effect of PEMF on marrow adiposity in postmenopausal women using magnetic resonance spectroscopy. METHODS Sixty-one postmenopausal women with osteopenia, aged 53 to 85 years, were randomly assigned to receive either PEMF treatment or placebo. The session was performed 3 times per week for 6 months. All women received adequate dietary calcium and vitamin D. Bone mineral density (BMD) by dual-energy x-ray absorptiometry, vertebral marrow fat content by magnetic resonance spectroscopy, and serum biomarkers were evaluated before and after 6 months of treatment. RESULTS A total of 27 (87.1%) and 25 (83.3%) women completed the treatment schedule in the PEMF and placebo groups, respectively. After the 6-month treatment, lumbar spine and hip BMD increased by 1.46% to 2.04%, serum bone-specific alkaline phosphatase increased by 3.23%, and C-terminal telopeptides of type 1 collagen decreased by 9.12% in the PEMF group (P < 0.05), whereas the mean percentage changes in BMD and serum biomarkers were not significant in the placebo group. Pulsed electromagnetic field treatment significantly reduced marrow fat fraction by 4.81%. The treatment difference between the 2 groups was -4.43% (95% confidence interval, -3.70% to -5.65%; P = 0.009). CONCLUSIONS Pulsed electromagnetic field is an effective physiotherapy in postmenopausal women, and this effect may, at least in part, regulate the amount of fat within the bone marrow. Magnetic resonance spectroscopy may serve as a complementary imaging biomarker for monitoring response to therapy in osteoporosis.