Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.

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.

Effectiveness of a Novel Food Composed of Leucine, Omega-3 Fatty Acids and Probiotic Lactobacillus paracasei PS23 for the Treatment of Sarcopenia in Elderly Subjects: A 2-Month Randomized Double-Blind Placebo-Controlled Trial.

Sarcopenia is a complex process characterized by a progressive decrease in muscle mass and strength. Various nutrients have been shown to be effective in supporting muscular performance. This randomized clinical trial aimed to evaluate the effectiveness of a 2-month administration of food for special medical purposes composed of omega-3 fatty acids (500 mg), leucine (2.5 g), and probiotic Lactobacillus paracasei PS23 (LPPS23), on appendicular lean mass (ALM), muscle performance, inflammatory status, and amino acid profile in sarcopenic patients. A total of 60 participants (aged 79.7 ± 4.8 years and a body mass index of 22.2 ± 2.1 kg/m2) were enrolled and randomly assigned to either intervention (n = 22) or placebo group (n = 28). Comparing the differences in effects between groups (intervention minus placebo effects), ALM increased significantly in the intervention group (p < 0.05), with no discernible change in the placebo group. Similarly, significant differences were also observed for the Tinetti scale (+2.39 points, p < 0.05), the SPPB total score (+2.22 points, p < 0.05), and the handgrip strength (4.09 kg, p < 0.05). Visceral adipose tissue significantly decreased in the intervention group compared to the placebo group at 60 days −0.69 g (95% CI: −1.09, 0.29) vs. 0.27 g (95% CI: −0.11, 0.65), groups difference −0.96 (95% CI: −1.52, 0.39, p = 0.001). A statistically significant increase in levels of valine, leucine, isoleucine, and total amino acid profiles was observed in the intervention group compared with the placebo group at 60 days (p = 0.001). When taken together, these beneficial effects may be attributed to the innovative composition of this special medical-purpose food which could be considered for the treatment of sarcopenia in the elderly.

Association between vitamin D and bisphenol A levels in an elderly Italian population: results from the InCHIANTI study.

Objective: This study aimed to evaluate the association between the endocrine-disrupting chemical, bisphenol A (BPA) on circulating levels of 25-hydroxy vitamin D (25(OD)D) and other vitamin D metabolites in an elderly population in Italy. Methods: This was a retrospective analysis of the InCHIANTI Biobank in Italy. The association between vitamin D metabolites namely 1,25(OH)D, 25(OH)D, parathyroid hormone (PTH) and BPA levels were evaluated. Multiple regression models were used to examine the association between predictor variables with 1,25(OH)D or 25(OH)D levels. Results: Samples from 299 individuals aged 72.8 ± 15.7 years were examined. Mean levels of BPA, 1,25(OH)D and 25(OH)D were 351.2 ± 511.6 ng/dL, 43.7 ± 16.9 pg/mL and 20.2 ± 12.1 ng/mL, respectively. One hundred eighty individuals (60.2%) were deficient (<20 ng/mL) in 25(OH)D and this population also presented higher BPA levels (527.9 ± 1289.5 ng/dL vs 86.9 ± 116.8 ng/dL, P < 0.0001). Univariate analysis revealed that BPA levels were negatively correlated with both 1,25(OH)D (r= -0.67, P < 0.0001) and 25(OH)D (r= -0.69, P < 0.0001). Multivariate regression revealed that PTH (ß: -0.23, 95% CI: -0.34, -0.13, P < 0.0001) and BPA (ß: -0.25, 95% CI: -0.3, -0.19, P < 0.0001) remained significantly associated with 25(OH)D levels while BPA was also associated with 1,25(OH)D levels (ß: -0.19, 95% CI: -0.22, -0.15, P < 0.0001). Receiver operating characteristic curve analysis showed that a BPA concentration of >113 ng/dL was the best cut-off to predict individuals deficient in 25(OH)D (area under the curve: 0.87, 95% CI: 0.82-0.90, P < 0.0001). Conclusion: The strong negative association between BPA and vitamin D in this elderly population warrants further investigation, particularly since this population is already at greatest risk of hypovitaminosis and fracture.

Antimicrobial Activity of Xibornol and a Xibornol-Based Formulation Against Gram-Positive Pathogens of the Respiratory Tract.

Xibornol is known since the 70s and a xibornol-based formulation is commercialized as spray suspension for the antisepsis of the oral cavity and as adjuvant in pharyngeal infections caused by Gram-positive microorganisms. Herein, we evaluated the antimicrobial activity of xibornol and the xibornol-based formulation against common pathogens of the upper and lower respiratory tract.Our results indicate that xibornol alone and the xibornol-based formulation have strong antibacterial action against Streptococcus pneumoniae, Streptococcus pyogenes, and Staphyloccus aureus, as well as against the two emerging pathogens Actinomyces israelii and Corynebacterium ulcerans. These findings highlight the antimicrobial potential of these drugs in the topical control of pathogenic Gram-positive bacteria of the respiratory tract.

On the roughness measurement on knee prostheses.

The majority of total knee replacements currently implanted present an articulation composed of two metal parts, femoral and tibial components, between which there is a polyethylene insert serving as a bearing surface. The finishing surface of the metal components is a very important factor in minimizing the polyethylene wear rate and, later, the gradual production of metal and plastic debris. Considering the role of surface roughness on volumetric wear rates, the purpose of this study is to develop a protocol for the roughness characterization of total knee prosthesis (TKP) metal components, taking into consideration a limited number of points on each surface. Six mobile TKP of different sizes (three size 2 and three size 6) were tested on a knee joint simulator to compare the wear behavior of each group. After 2 million cycles the weight loss by the polyethylene inserts was measured with gravimetric method and the surface roughness of the metallic components was assessed in terms of average surface roughness, Ra, skewness, Rsk, and total roughness, Rt. Roughness measurement involved 29 points on each femoral condyle and 26 points on each metal tibial plate. The data collected has shown an increased roughness upon wear testing for both the investigated TKP sizes. No statistical differences were observed between the two groups for both the parameters Ra, Rsk, and Rt. The surface of all metallic components became more negatively skewed, indicating diminishing peaks. The various parameters were correlated to the volumetric loss using a linear regression analysis.

A new protocol from real joint motion data for wear simulation in total knee arthroplasty: stair climbing.

In its normal lifespan, a knee prosthesis must bear highly demanding loading conditions, going beyond the sole activity of level walking required by ISO standard 14243. We have developed a protocol for in vitro wear simulation of stair climbing on a displacement controlled knee simulator. The flexion/extension angle, intra/extra rotation angle, and antero/posterior translation were obtained in patients by three-dimensional video-fluoroscopy. Axial load data were collected by gait analysis. Kinematics and load data revealed a good consistence across patients, in spite of the different prosthesis size. The protocol was then implemented and tested on a displacement controlled knee wear simulator, showing an accurate reproduction of stair climbing waveforms with a relative error lower than 5%.

Combined effect of the body mass index and implant size on the wear of retrieved total knee prostheses.

Total Knee Arthroplasty is a well-established surgical procedure performed to relieve pain and to restore function in knee osteoarthritis. A proper choice of the implant size is mandatory in order to guarantee the success of the implant and to respect the bone stock of tibial plateau and femoral condyles. The aim of this study was to investigate the combined effect of Body Mass Index and implant size on the wear damage of retrieved knee implants, a still debated subject. To this purpose, twelve total knee prostheses of the same design (NexGen, Zimmer, Warsaw, Indiana) but with different sizes were investigated. These prostheses were all cemented fixed bearing inserts and posterior stabilised. Roughness analyses were performed on femoral components to assess surface modifications. Micro-Raman spectroscopic characterization was performed on polyethylene inserts to evaluate crystallinity changes. A worsening of the surface and a nonhomogeneous aspect was observed in the prostheses characterized by a high ratio between preoperative Body Mass Index and implant size, which we called Ф factor. Delamination, a good indicator for polyethylene osteolysis, was more pronounced in the inserts having a high Ф than in those with a low Ф. Micro-Raman analyses showed more significant crystallinity changes in the prostheses of lower size, in agreement with the results previously obtained in vitro. The findings of the present study suggested that the Ф factor can be considered a predictor factor of the Total Knee Arthroplasty overall performance. Potentially, it could be used as a discriminating factor to redact Total Knee Arthroplasty outcome and prevent complications.

Toward the interpretation of the combined effect of size and body weight on the tribological performance of total knee prostheses.

PURPOSE: The research questions of the present study were: (1) Is total knee prosthesis wear behaviour influenced by implant size, body weight and their combined effect? (2) Are these findings significant and helpful from a clinical point of view? METHODS: Two very different sizes of the same total knee prosthesis (TKP), previously tested with ISO 14243 parameters, were tested on a knee simulator for a further two million cycles using a modified ISO 14243 load waveform. Roughness examination was performed on the metallic components. Gravimetric and micro-Raman spectroscopic analyses were carried out on the polyethylene inserts. RESULTS: The average volumetric mass loss was 69 ± 3 mm(3) and 88 ± 4 mm(3) for smaller and bigger size, respectively. Bigger TKPs are little influenced by an increased load, while the wear trend of the smaller TKP showed a redoubled slope, and more significant morphology changes were observed. However, the two sizes seem to behave similarly when subjected to a load increase of 15 %; the slope of the volumetric mass loss trend was comparable for the two sets of inserts, which did not appear significantly different also at the molecular level. Roughness average parameters of the lateral femoral condyle support this evidence. CONCLUSIONS: It can be asserted that the body weight and implant size are relevant to the understanding of TKP wear behaviour. A post-implantation body weight increase in a patient with smaller knee dimensions could results in more critical effects on prosthesis long-term performance.

Wireless insufflation of the gastrointestinal tract.

Despite clear patient experience advantages, low specificity rates have thus far prevented swallowable capsule endoscopes from replacing traditional endoscopy for diagnosis of colon disease. One explanation for this is that capsule endoscopes lack the ability to provide insufflation, which traditional endoscopes use to distend the intestine for a clear view of the internal wall. To provide a means of insufflation from a wireless capsule platform, in this paper we use biocompatible effervescent chemical reactions to convert liquids and powders carried onboard a capsule into gas. We experimentally evaluate the quantity of gas needed to enhance capsule visualization and locomotion, and determine how much gas can be generated from a given volume of reactants. These experiments motivate the design of a wireless insufflation capsule, which is evaluated in ex vivo experiments. These experiments illustrate the feasibility of enhancing visualization and locomotion of endoscopic capsules through wireless insufflation.