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Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.
Rondanelli, M, Minisola, S, Barale, M, Barbaro, D, Mansueto, F, Battaglia, S, Bonaccorsi, G, Caliri, S, Cavioni, A, Colangelo, L, et al
Aging clinical and experimental research. 2024;36(1):38
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The occurrence of fractures and osteoporosis are significant concerns in elderly adults, as ageing remains one of the primary risk factors for these conditions. While the incidence of fracture and risk may vary, the incidence of fragility fractures significantly increases with advancing age, particularly after the age of 50 years. This study's aim was to evaluate the adherence, tolerability, and safety of calcium citrate administration in an "outpatient" population in routine clinical practice. This study was a non-interventional, prospective, multicentre study. Two-hundred and sixty-eight individuals (comprised 245 females (91.4%) and 23 males (8.6%)) were enrolled. Results showed a high rate of adherence to calcium citrate supplementation over a one-year period in osteopenic elderly subjects. Additionally, the incidence of adverse reactions was low (3.9%), further emphasizing the tolerability of calcium citrate. Authors concluded that future studies designed to assess the long-term impact of calcium citrate supplementation on hard endpoints, such as bone density, fractures/falls, quality of life measures and adherence are needed.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The occurrence of fractures and osteoporosis are significant concerns in older adults, as ageing remains one of the primary risk factors for this condition.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- This non-interventional, prospective multicentre study suggests a 91% adherence to calcium citrate supplementation over one year in elderly osteopenic patients with generally good (80%) tolerability and 4% reporting gastrointestinal adverse effects.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
A non-interventional, prospective multicentre study was conducted to evaluate the adherence, safety, and tolerability of calcium citrate supplementation in elderly osteopenic subjects.
Method:
A total of 231 Caucasian female (91%) and male (8%) participants with a median age of 70 received 500mg of calcium citrate supplementation daily for one year. Adherence was assessed based on tolerability, compliance, and persistence. Safety evaluations included monitoring of adverse reactions (ARs), physical examinations, and clinical laboratory evaluations.
Results
A total of 222 out of 231 participants (96%) completed the study. Nine subjects did not return for assessments or complete their diaries.
The primary and secondary findings of this study were as follows:
- An average adherence of 91% of oral calcium citrate supplementation was observed which was higher than the reported reference rate of 57% (p = 0.0179).
- Subjects with adherence <80% experienced a higher frequency of adverse events compared to those with adherence >80% (32/77; 42% vs 16/145%, (p = 0.0001).
- Gastrointestinal ARs were the most commonly reported, with constipation comprising 50% of all reported ARs.
- Reductions in systolic (130.7 ± 16.9 mmHg to 127.9 ± 14.5 mmHg) (p = 0.0102) and diastolic blood pressure 79.5 ± 8.7 mmHg to 77.4 ± 8.6 mmHg (baseline to V2) (p = 0.0116) were observed from baseline to the second visit.
- Positive changes were also noted in nutritional status (p = 0.0116), circulatory system disorders (p = 0.0001), and muscles/skeleton disorders (p = 0.0067) from baseline to post-baseline visit.
Conclusion:
This study revealed a 91% adherence to calcium citrate supplementation over one year in older adults with osteopenia, Additionally, the 4% incidents of ARs reported were related to gastrointestinal disorders.
Clinical practice applications:
- The prevalence of osteoporosis rises as individuals age, with approximately 10% of women at 60 years, 20% at 70 years, and 40% at 80 years.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- The safety of calcium supplements remains controversial regarding an increased risk of cardiovascular events. Therefore, it is essential to investigate the safety profile of calcium in these populations.
- This study reported adherence, tolerability, and safety of calcium citrate supplementation in osteopenic elderly patients with 4% of patients reporting gastrointestinal adverse effects.
Considerations for future research:
- This study was conducted on 91% Caucasian females and 8% males with a mean age of 70 years therefore, there is a need to include more male and Asian participants from various age groups in further research.
- Future studies are needed to assess the long-term impact of calcium citrate supplementation on bone density, fractures, and quality of life.
Abstract
BACKGROUND Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. AIM: The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. METHODS In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. RESULTS A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). CONCLUSION This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.
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Effect of a Hop Extract Standardized in 8-Prenylnaringenin on Bone Health and Gut Microbiome in Postmenopausal Women with Osteopenia: A One-Year Randomized, Double-Blind, Placebo-Controlled Trial.
Lecomte, M, Tomassi, D, Rizzoli, R, Tenon, M, Berton, T, Harney, S, Fança-Berthon, P
Nutrients. 2023;15(12)
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Osteoporosis is a bone condition characterized by weakened and brittle bones, leading to an increased risk of fractures. Oestrogens play a vital role in maintaining bone health, whereby oestrogen deficiency elevates the risk of osteoporosis and fractures, particularly in menopausal women due to the decline in oestrogen levels. Phytoestrogens, plant-derived compounds capable of interacting with human oestrogen receptors, have presented an intriguing non-pharmaceutical avenue for preventing bone loss. Other phytoestrogens have received some attention in the field, however, limited human research exists on prenylflavonoids, a phytoestrogens found in hops (Humulus lupulus). This randomized, double-blinded, placebo-controlled trial aimed to investigate the effects of a year-long supplementation of standardised hop extract (8-PN) Lifenol® on bone mineral density in postmenopausal women. Additionally, the study explored potential mechanisms, particularly focusing on changes in gut bacteria. Notably, gut bacteria play a role in bone metabolism and the pathogenesis of osteoporosis. They are also, along with the liver, responsible for converting hops phenols into active phytoestrogenic compounds. The trial was completed by 95 postmenopausal, women with Osteopenia aged 50 to 85. They all received calcium and vitamin D3 tablets in addition either a hop extract (100mcg) or a placebo for 48 weeks. Changes were monitored using DXA scans for bone mineral density (BMD) and bone metabolism, blood samples for markers for bone health, a quality of life questionnaire, gut microbiome testing, and tests for short-chain fatty acid (SCFA) levels. In conclusion, the intake of hop extract confirmed a previously observed trend of a slight increase in total bone mineral density (BMD), in addition to the benefits linked to calcium and vitamin D supplementation. Although there were no significant changes in the composition of gut bacteria and SCFA levels, the hop extract candidates had a higher abundance of specific genera associated with total body BMD, suggesting a potential positive impact. Larger studies are required to validate these findings.
Abstract
Estrogen deficiency increases the risk of osteoporosis and fracture. The aim of this study was to investigate whether a hop extract standardized in 8-prenylnaringenin (8-PN), a potent phytoestrogen, could improve bone status of osteopenic women and to explore the gut microbiome roles in this effect. In this double-blind, placebo-controlled, randomized trial, 100 postmenopausal, osteopenic women were supplemented with calcium and vitamin D3 (CaD) tablets and either a hop extract (HE) standardized in 8-PN (n = 50) or a placebo (n = 50) for 48 weeks. Bone mineral density (BMD) and bone metabolism were assessed by DXA measurements and plasma bone biomarkers, respectively. Participant's quality of life (SF-36), gut microbiome composition, and short-chain fatty acid (SCFA) levels were also investigated. In addition to the CaD supplements, 48 weeks of HE supplementation increased total body BMD (1.8 ± 0.4% vs. baseline, p < 0.0001; 1.0 ± 0.6% vs. placebo, p = 0.08), with a higher proportion of women experiencing an increase ≥1% compared to placebo (odds ratio: 2.41 ± 1.07, p < 0.05). An increase in the SF-36 physical functioning score was observed with HE versus placebo (p = 0.05). Gut microbiome α-diversity and SCFA levels did not differ between groups. However, a higher abundance of genera Turicibacter and Shigella was observed in the HE group; both genera have been previously identified as associated with total body BMD. These results suggest that an 8-PN standardized hop extract could beneficially impact bone health of postmenopausal women with osteopenia.
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Does adding exercise or physical activity to pharmacological osteoporosis therapy in patients with increased fracture risk improve bone mineral density and lower fracture risk? A systematic review and meta-analysis.
Schumm, AK, Craige, EA, Arora, NK, Owen, PJ, Mundell, NL, Buehring, B, Maus, U, Belavy, DL
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2023;34(11):1867-1880
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Osteoporosis, a progressive systematic skeletal disease is caused by diminished bone density and strength, which may increase the risk of fragility fractures in the spine, pelvis, femur etc. Women are at greater risk of developing osteoporosis. Osteopenia is an intermediary stage of reduced bone mineral density before progressing into the osteoporosis disease state. Exercise and pharmacological therapies are considered two effective strategies commonly used in the treatment of osteoporosis. Exercise may help to improve bone mineral density, strength and muscle mass and reduce the risk of fractures. This systematic review and meta-analysis of five parallel-arm randomised controlled trials investigated the combined effect of exercise and pharmacological therapy on bone mineral density, bone turnover markers, fractures and fracture healing in patients with osteopenia and osteoporosis. This systematic review and meta-analysis showed a non-significant improvement in bone mineral density in patients with osteopenia and osteoporosis followed by combined pharmacological treatment with exercise. Pharmacological therapy alone showed improvement and maintenance of bone mineral density. There was no evidence for the improvement in fragility fracture healing. Due to the low evidence and high heterogeneity of included studies, further robust studies are required to evaluate the combined effect of exercise and pharmacological therapy in people with systematic skeletal disease. Healthcare professionals can use this study to understand the benefits of pharmacological therapy in improving osteoporosis and osteopenia and the potential of adding exercise as a therapeutic strategy in clinical practice.
Abstract
This prospectively registered systematic review and meta-analysis examines whether exercise (EX) training has an additive effect to osteoanabolic and/or antiresorptive pharmacological therapy (PT) in people with osteoporosis on bone mineral density (BMD), bone turnover markers (BTMs), fracture healing, and fractures. Four databases (inception to 6 May 2022), 5 trial registries, and reference lists were searched. Included were randomized controlled trials comparing the effect of EX + PT vs. PT with regard to BMD, BTM, fracture healing, and fractures. Risk of bias was assessed using the Cochrane RoB2 and certainty of evidence by the GRADE approach. Random-effects meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustment was used to estimate standardized mean differences and 95% confidence intervals. Out of 2593 records, five RCTs with 530 participants were included. Meta-analysis showed with very low certainty evidence and wide confidence intervals that EX + PT compared to PT had larger effect sizes for BMD at 12 months at the hip (SMD [95%CI]: 0.18 [- 1.71; 2.06], n = 3 studies), tibia (0.25 [- 4.85; 5.34], n = 2), lumbar spine (0.20 [- 1.15; 1.55], n = 4), and forearm (0.05 [- 0.35; 0.46], n = 3), but not femoral neck (- 0.03 [- 1.80; 1.75], n = 3). Furthermore, no improvement was revealed for BTM such as bone ALP (- 0.68 [- 5.88; 4.53], n = 3), PINP (- 0.74 [- 10.42; 8.93], n = 2), and CTX-I (- 0.69 [- 9.61; 8.23], n = 2), but with very wide confidence intervals. Three potentially relevant ongoing trials were identified via registries. No data were found for fracture healing or fracture outcomes. It remains unclear whether EX has an additive impact to PT in people with osteoporosis. High-quality, adequately powered, targetted RCTs are required. PROTOCOL REGISTRATION PROSPERO CRD42022336132.
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Effects of an 18-month community-based, multifaceted, exercise program on patient-reported outcomes in older adults at risk of fracture: secondary analysis of a randomised controlled trial.
Talevski, J, Gianoudis, J, Bailey, CA, Ebeling, PR, Nowson, CA, Hill, KD, Sanders, KM, Daly, RM
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2023;34(5):891-900
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Fragility fractures are associated with both personal and healthcare system burdens. It is well established that bone loss leading to osteopenia or osteoporosis results in increased risk of fractures. Prescription of pharmacological agents is commonly used as first-line treatment. The aim of this study was to evaluate the effect of the Osteo-cise: Strong Bones for Life program on the patient-reported outcomes including health related quality of life (HRQoL), osteoporosis knowledge and osteoporosis attitudes and beliefs. This study is a secondary analysis of an 18-month randomised controlled trial in which participants were randomly allocated to either the community-based Osteo-cise: Strong Bones for Life program (‘Osteo-cise’) or a standard care control group. Results showed that there were no significant effects on HRQoL, osteoporosis knowledge or osteoporosis attitudes and beliefs compared with usual care. However, per protocol analyses revealed that those most adherent to exercise training did experience significant improvements in both HRQoL and osteoporosis knowledge compared with usual care. Authors concluded that their findings highlight the need to identify strategies that promote long-term adherence to multifaceted exercise programs in community-dwelling older adults.
Abstract
UNLABELLED This study identified that an 18-month community-based, multifaceted, exercise program consisting of resistance, weight-bearing impact, and balance/mobility training combined with osteoporosis education and behavioural support can improve health-related quality of life (HRQoL) and osteoporosis knowledge in older adults at risk of fracture, but only for those adherent to the exercise regime. PURPOSE To evaluate the effects of an 18-month community-based exercise, osteoporosis education and behaviour change program (Osteo-cise: Strong Bones for Life) on HRQoL, osteoporosis knowledge and osteoporosis health beliefs. METHODS This was a secondary analysis of an 18-month randomised controlled trial in which 162 older adults aged ≥ 60 years with osteopenia or increased falls/fracture risk were randomized to the Osteo-cise program (n = 81) or control group (n = 81). The program consisted of progressive resistance, weight-bearing impact and balance training (3 days/week); osteoporosis education to facilitate self-management of musculoskeletal health and behavioural support to enhance adherence to exercise. HRQoL, osteoporosis knowledge and osteoporosis health beliefs were assessed using the EuroQoL questionnaire (EQ-5D-3L), Osteoporosis Knowledge Assessment Tool and Osteoporosis Health Belief Scale, respectively. RESULTS Overall, 148 participants (91%) completed the trial. Mean exercise adherence was 55% and mean attendance for the three osteoporosis educational sessions ranged from 63-82%. After 12 and 18 months, there were no significant effects of the Osteo-cise program on HRQoL, osteoporosis knowledge or health beliefs relative to controls. Per protocol analyses (≥ 66% exercise adherence; n = 41) revealed a significant net benefit in EQ-5D-3L utility for the Osteo-cise group relative to controls after 12 months (P = 0.024) and 18 months (P = 0.029) and a significant net improvement in osteoporosis knowledge scores at 18 months (P = 0.014). CONCLUSION This study supports the importance of adherence to exercise regimes, as adherence to the Osteo-cise: Strong Bones for Life program was associated with improvements in HRQoL and osteoporosis knowledge in older adults at increased risk for falls and fractures. TRIAL REGISTRATION NUMBER ACTRN12609000100291.
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Association of Coffee and Tea Intake with Bone Mineral Density and Hip Fracture: A Meta-Analysis.
Chen, CC, Shen, YM, Li, SB, Huang, SW, Kuo, YJ, Chen, YP
Medicina (Kaunas, Lithuania). 2023;59(6)
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Osteoporosis is associated with severe complications, such as osteoporotic fracture and fracture-related functional disability. Risk factors for osteoporosis must be identified and validated at the earliest. The aim of this study was to investigate the association of coffee and tea intake with bone mass density (BMD) and hip fracture risk. This study was a systematic review and meta-analysis of 106 studies. In total, 416,847 individuals (BMD related studies, 99,750 individuals; hip fracture–related studies, 408,562 individuals) were included in the final analysis. Results showed that the daily intake of caffeinated beverages, such as coffee and tea, is not associated with BMD or hip fracture risk, particularly in postmenopausal women. Authors concluded that their findings help reduce the inconsistency in the current literature. Furthermore, it may serve as a reference for future studies aimed at identifying the risk factor for osteoporosis.
Abstract
Background and Objectives: Osteoporosis is characterized by low bone mass and high bone fragility. Findings regarding the association of coffee and tea intake with osteoporosis have been inconsistent. We conducted this meta-analysis to investigate whether coffee and tea intake is associated with low bone mineral density (BMD) and high hip fracture risk. Materials and Methods: PubMed, MEDLINE, and Embase were searched for relevant studies published before 2022. Studies on the effects of coffee/tea intake on hip fracture/BMD were included in our meta-analysis, whereas those focusing on specific disease groups and those with no relevant coffee/tea intake data were excluded. We assessed mean difference (MD; for BMD) and pooled hazard ratio (HR; for hip fracture) values with 95% confidence interval (CI) values. The cohort was divided into high- and low-intake groups considering the thresholds of 1 and 2 cups/day for tea and coffee, respectively. Results: Our meta-analysis included 20 studies comprising 508,312 individuals. The pooled MD was 0.020 for coffee (95% CI, -0.003 to 0.044) and 0.039 for tea (95% CI, -0.012 to 0.09), whereas the pooled HR was 1.008 for coffee (95% CI, 0.760 to 1.337) and 0.93 for tea (95% CI, 0.84 to 1.03). Conclusions: Our meta-analysis results suggest that daily coffee or tea consumption is not associated with BMD or hip fracture risk.
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Dietary Acid Load Was Positively Associated with the Risk of Hip Fracture in Elderly Adults.
Li, CF, Liu, YP, Liu, CY, Zhu, HL, Wu, BH, Li, BL, Chen, YM
Nutrients. 2022;14(18)
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Osteoporosis causes huge disease and economic burdens worldwide. Hip fracture is deemed the most devastating result of osteoporosis owing to its high disability and mortality rate. Dietary acid load (DAL) is often used to evaluate the acid–base equilibrium state of the body. The aim of this study was to examine the association between DAL and the risk of hip fracture among middle-aged and older people (Chinese). This study is a large 1:1 matched case–control study with a total of 1070 (women, 795; men, 275) pairs of cases and controls. Results show that DAL had significant positive associations with the risk of hip fracture among middle-aged and older Chinese people especially in those with a lower body mass index - less than 23 kg/m2. Authors conclude that future prospective studies with objective DAL measures are required in order to further confirm the findings of this study.
Abstract
Previous studies have shown that dietary acid load (DAL) harms bone health, but the evidence is inconsistent and insufficient. This study examined the relationships between DAL and the risk of hip fracture. This case-control study contained 1070 pairs of 1:1 age-, city-, and gender-matched incident cases and controls (mean age, 71 years) recruited in Guangdong, China. Dietary information was collected using a validated 79-item food frequency questionnaire through face-to-face interviews. DAL was estimated based on established algorithms for the potential renal acid load (PRAL) and net endogenous acid production (NEAP). Higher PRAL and NEAP were dose-dependently associated with a higher risk of hip fracture in both the conditional logistic regression model and restricted cubic spline analysis after adjusting for potential covariates. The multivariate-adjusted odds ratios and 95% CI of hip fracture for tertiles 2 and 3 (vs. 1) of DAL were 1.63 (1.18, 2.25) and 1.92 (1.36, 2.71) for PRAL and 1.81 (1.30, 2.53) and 2.55 (1.76, 3.71) for NEAP in all participants (all p-trends < 0.001), respectively. Subgroup analyses showed more pronounced associations in participants with a lower body mass index. Our findings suggested positive associations between the estimated DAL and the risk of hip fractures in the elderly Chinese population.
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One-year supplementation with Lactobacillus reuteri ATCC PTA 6475 counteracts a degradation of gut microbiota in older women with low bone mineral density.
Li, P, Ji, B, Luo, H, Sundh, D, Lorentzon, M, Nielsen, J
NPJ biofilms and microbiomes. 2022;8(1):84
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Osteoporosis is a highly prevalent bone disease in the elderly population and is characterised by decreased bone mineral density, deteriorated bone microarchitecture, reduced bone strength and increased susceptibility to fragility fractures. Due to the lack of awareness about osteoporosis, there is the need to develop a novel and effective intervention for its prevention and treatment. The aim of this study was to gain mechanistic insight into the effect of Lactobacillus reuteri ATCC PTA 6475 on bone metabolism and identify factors important for a good response to the probiotic. This study was based on a placebo-controlled cohort trial where 68 elderly women had been randomised to supplementation with the probiotic strain L. reuteri ATCC PTA 6475 or placebo. For this secondary analysis, 20 out of the 68 elderly women with bone loss who supplemented with probiotic L. reuteri ATCC PTA 6475 were selected. Results showed that after one-year probiotic supplementation, there was decreased inflammation and significantly increased gene richness of the gut microbiota in the good responders, whereas there was altered microbial composition and function, including enrichment of E. coli and its biofilm formation in the poor responders. Authors conclude that L. reuteri ATCC PTA 6475 supplementation might promote bone formation by modulating the gut microbiota composition and function, which could be crucial for the development of novel osteoporosis treatments.
Abstract
Recent studies have shown that probiotic supplementation has beneficial effects on bone metabolism. In a randomized controlled trial (RCT) we demonstrated that supplementation of Lactobacillus reuteri ATCC PTA 6475 reduced bone loss in older women with low bone mineral density. To investigate the mechanisms underlying the effect of L. reuteri ATCC PTA 6475 on bone metabolism, 20 women with the highest changes (good responders) and the lowest changes (poor responders) in tibia total volumetric BMD after one-year supplementation were selected from our previous RCT. In the current study we characterized the gut microbiome composition and function as well as serum metabolome in good responders and poor responders to the probiotic treatment as a secondary analysis. Although there were no significant differences in the microbial composition at high taxonomic levels, gene richness of the gut microbiota was significantly higher (P < 0.01 by the Wilcoxon rank-sum test) and inflammatory state was improved (P < 0.05 by the Wilcoxon signed-rank test) in the good responders at the end of the 12-month daily supplementation. Moreover, detrimental changes including the enrichment of E. coli (adjusted P < 0.05 by DESeq2) and its biofilm formation (P < 0.05 by GSA) observed in the poor responders were alleviated in the good responders by the treatment. Our results indicate that L. reuteri ATCC PTA 6475 supplementation has the potential to prevent a deterioration of the gut microbiota and inflammatory status in elderly women with low bone mineral density, which might have beneficial effects on bone metabolism.
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Meta-Analysis of Effects of Nutritional Intervention Combined with Calcium Carbonate D3 Tablets on Bone Mineral Density, Bone Metabolism, and Curative Effect in Patients with Osteoporosis.
Ni, H, Zhang, S, Niu, X, Dai, S
Contrast media & molecular imaging. 2022;2022:3670007
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Osteoporosis is characterised by reduced bone mineral density and changes in bone metabolism, which may increase the risk of bone fractures. Elderly people are more at risk of developing osteoporosis. A calcium carbonate D3 tablet combined with nutritional intervention is commonly recommended by health professionals for the treatment of osteoporosis in the elderly. In this meta-analysis, 10 Chinese literature, 7 high-quality literature and 3 low-quality research were examined to determine the effect of nutritional intervention with calcium carbonate D3 tablets on changes in bone mineral density and bone metabolism in osteoporosis patients. Nutritional intervention in combination with calcium carbonate tablet supplementation showed significant efficacy compared to the use of a single drug. In the combined intervention group, osteocalcin levels, serum alkaline phosphatase levels, serum calcium levels, blood phosphorus levels, and bone mineral density were significantly higher than those in the monotherapy group. This study provides healthcare professionals with an opportunity to gain a better understanding of the efficacy of nutritional intervention coupled with calcium carbonate D3 supplementation on osteocalcin levels, serum alkaline phosphatase levels, serum calcium levels, blood phosphorus levels, and bone mineral density in osteoporosis patients. The validity of the data and the clinical utility of different combinations of therapeutic strategies require further robust research.
Abstract
To investigate the changes in bone mineral density, bone metabolism, and efficacy of nutritional intervention combined with calcium carbonate D3 tablets in patients with osteoporosis, a RevMan 5.2 software meta-analysis was conducted in this study. According to the therapeutic direction of nutritional intervention combined with calcium carbonate D3 tablets for osteoporosis patients, relevant literature were searched in Wanfang Medical, CNKI, VIP, and PubMed literature databases at home and abroad. Keywords included bone mineral density, bone metabolism, blood calcium (Ca), blood phosphorus (P), osteocalcin (OC), bone mineral density (BMD), serum alkaline phosphatase (ALP), efficacy, osteoporosis, and nutritional intervention. Literature that met the criteria were deleted, and meta-analysis was performed using RevMan 5.2 software. The results indicate that a total of 10 Chinese literature were included. Compared with the monotherapy group, the clinical efficacy, osteocalcin, BMD, alkaline phosphatase, calcium, and phosphorus were significantly higher in the combination group (P < 0.05). Based on calcium carbonate D3, treatment combined with nutritional intervention can enhance the clinical efficacy, bone metabolism, and bone mineral density of patients with osteoporosis, and nutritional intervention combined with calcium carbonate D3 tablets is a feasible program to promote the recovery of patients with osteoporosis.
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Probiotic supplements and bone health in postmenopausal women: a meta-analysis of randomised controlled trials.
Yu, J, Cao, G, Yuan, S, Luo, C, Yu, J, Cai, M
BMJ open. 2021;11(3):e041393
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Osteoporosis is a disease where bone density is decreased and is often seen in postmenopausal women. Current prescribed treatments are costly and can often have serious side effects and as a result natural treatments are often requested. Probiotics have been shown in previous studies to be of benefit to bones, however no large review of all the available studies has been performed. This systematic review and meta-analysis of current randomised control trials (RCT’s) aimed to summarise the effect of probiotics on bone density in postmenopausal women. The results showed that only five RCT’s were available on the effect of probiotics on bone density of which there were 497 postmenopausal women. Bone density at the base of the spine was increased in women taking probiotics, however there was no difference seen in bone density of the hip. Bone markers for bone degradation were decreased, however other markers associated with bone density changes were unaffected. It was concluded that probiotics may increase bone density at the base of the spine, however more high-quality studies are needed. This study could be used by healthcare professionals to understand how probiotics may be of benefit to postmenopausal women, however definitive recommendations based on this study may need to be made with caution.
Abstract
OBJECTIVE Osteoporosis is a common disease in postmenopausal women. Several studies have analysed the associations between dietary supplementation with probiotics and bone health in postmenopausal women, but the results are still controversial. We conducted this meta-analysis to assess the effects of probiotics supplement on bone mineral density (BMD) and bone turnover markers for postmenopausal women. DESIGN Systematic review and meta-analysis. METHODS We systematically searched PubMed, EMBASE and the Cochrane Library from their inception to November 2020 for randomised controlled trials (RCTs) assessing probiotic supplements and osteoporosis in postmenopausal women. Study-specific risk estimates were combined using random-effect models. RESULTS Five RCTs (n=497) were included. Probiotic supplements were associated with a significantly higher BMD in the lumbar spine (standardised mean difference, SMD=0.27, 95% CI 0.09 to 0.44) than in control. There was no difference between probiotic supplements and BMD in hips (SMD=0.22, 95% CI -0.07 to 0.52). Collagen type 1 cross-linked C-telopeptide levels in the treatment groups were significantly lower than those of the placebo group (SMD=-0.34, 95% CI -0.60 to -0.09). In subgroup meta-analysis, levels of bone-specific alkaline phosphatase, osteoprotegerin, osteocalcin and tumour necrosis factor did not differ between the probiotic and placebo groups. CONCLUSIONS We conclude cautiously that supplementation with probiotics could increase lumbar BMD. More RCTs are recommended to validate or update these results.
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Regular Supplementation With Resveratrol Improves Bone Mineral Density in Postmenopausal Women: A Randomized, Placebo-Controlled Trial.
Wong, RH, Thaung Zaw, JJ, Xian, CJ, Howe, PR
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2020;35(11):2121-2131
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Osteoporosis is a silent disease characterized by progressive deterioration of bone tissue, gradually compromising bone strength. Phytoestrogens such as soy isoflavones and resveratrol have structural similarity to oestrogen and can bind to oestrogen receptors to exert a multitude of benefits for which oestrogen is responsible, and they have attracted interest as potential bone health therapies in oestrogen-deficient postmenopausal women. The aim of this study was to investigate whether (a) resveratrol has beneficial effects on bone mineral density (BMD) in postmenopausal women, and (b) there is any potential interaction between resveratrol and vitamin D and/or calcium supplements. The Resveratrol for Healthy Aging in Women trial is a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention. This study focuses on outcomes for bone health and biomarkers of bone metabolism. Results show that low-dose resveratrol supplementation significantly improved BMD of the lumbar spine and femoral neck. It also reduced the bone resorption marker, CTX, in postmenopausal women. The magnitude of benefit was greater for women with suboptimal bone metabolism. Authors conclude that improvement of the microcirculation may be an additional area to target in preventing postmenopausal osteoporosis.
Abstract
Resveratrol, a naturally occurring polyphenol in red grapes and berries, can act as a phytoestrogen. It has been shown to improve both systemic and cerebral circulatory functions, possibly through activation of endothelial estrogen receptors. in vitro and in vivo studies in rodent models also indicate a bone-protective role for resveratrol, particularly in ovariectomized rat models that mimic postmenopausal osteoporosis caused by estrogen deficiency. Hypothesizing a circulatory benefit of resveratrol in bone tissue, we investigated whether resveratrol supplementation could improve bone health in postmenopausal women. The Resveratrol for Healthy Aging in Women (RESHAW) trial was a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention conducted to evaluate the effects of resveratrol (75 mg twice daily) on cognition, cerebrovascular function, bone health, cardiometabolic markers, and well-being in postmenopausal women. After 12 months of supplementation with resveratrol versus placebo, there were positive effects on bone density in the lumbar spine (+0.016 ± 0.003 g/cm2 ) and neck of femur (+0.005 ± 0.002 g/cm2 ), which were accompanied by a 7.24% reduction in C-terminal telopeptide type-1 collagen levels, a bone resorption marker, compared with placebo. The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070 ± 0.018) and a reduction in the 10-year probability of major and hip fracture risk. The magnitude of improvement was higher in women with poor bone health biomarker status. Importantly, the improvement in femoral neck T-score with resveratrol correlated with improvement in perfusion. Our subanalysis also revealed that the bone-protective benefit of resveratrol was greater in participants who supplemented with vitamin D plus calcium. Regular supplementation with 75 mg of resveratrol twice daily has the potential to slow bone loss in the lumbar spine and femoral neck, common fracture sites in postmenopausal women without overt osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.