Calcium carbonate 600mg / Magnesium carbonate 125mg chewable tablets

ObjectiveWhile the effect of the RANKL-inhibitor denosumab on serum minerals is well-documented, its impact on seminal fluid minerals is poorly understood. This study examines the correlation between the high levels of soluble-RANKL, osteoprotegerin (OPG), and minerals in seminal fluid and whether this can be influenced by denosumab.MethodsTwo cohorts comprised this study: 100 young men from the general Danish population with no reported fertility issues, and 91 infertile men who were treated with a single dose of denosumab (60 mg), or placebo in a randomized controlled trial assessing the effect on semen quality. Each man underwent a physical examination and semen analysis, including analysis of soluble RANKL, OPG, calcium, magnesium, and phosphate in the seminal fluid.ResultsIn both men from the general population and infertile men, seminal OPG concentrations were positively correlated with seminal calcium (rnormal=0.54 and rinfertile=0.81), seminal magnesium (rnormal=0.58 and rinfertile=0.75), and a weak negative correlation was seen with seminal phosphate (rnormal=-0.17 and rinfertile=-0.34) concentrations. Seminal soluble RANKL was not associated with seminal minerals. Following 60 mg denosumab treatment, no changes were observed after 160 days in seminal calcium (p = 0.42), magnesium (p = 0.55), or phosphate concentrations (p = 0.63). Changes in seminal OPG were moderately negatively correlated with changes in serum AMH (r=-0.32), LH (r=-0.30), and FSH (r=-0.31).ConclusionA strong correlation between OPG and minerals in seminal fluids from both normal and infertile men suggests that the release of these factors by the prostate or seminal vesicle is regulated by the same factors, but cannot be modified by a short-term systemic RANKL inhibition with denosumab.Clinical trial registrationClinicalTrials.gov NCT03030196. Registered January 24, 2017.

Abstract licence: CC BY

BackgroundThis study aimed to evaluate the efficacy and safety of ferric citrate tablets in Chinese patients with hyperphosphatemia undergoing maintenance hemodialysis (MHD).MethodsIn this phase III, multicenter, randomized, open-label, non-inferiority trial, patients with hyperphosphatemia on maintenance hemodialysis were randomly assigned to receive either ferric citrate or sevelamer carbonate tablets for 12 weeks. The primary endpoint was the change in serum phosphorus levels from baseline to week 12, with a non-inferiority margin of 0.32 mmol/L. Secondary endpoints included changes in serum calcium, intact parathyroid hormone, and safety assessments.ResultsA total of 239 patients were randomized to the ferric citrate group (n = 119) or the sevelamer carbonate group (n = 120). The mean change in serum phosphorus levels was -0.70 ± 0.50 mmol/L in the ferric citrate group and -0.61 ± 0.59 mmol/L in the sevelamer carbonate group (least squares mean difference, -0.09 mmol/L; 95% CI, -0.24 to 0.05 mmol/L; non-inferiority margin, 0.32 mmol/L). No significant inter-group differences were found in the percentage of patients achieving target phosphorus levels (49.09% vs. 48.28%, p = 0.902). Ferric citrate significantly improved iron-related parameters and hemoglobin levels. Most treatment-emergent adverse events were mild, with gastrointestinal disorders being the most common.ConclusionsFerric citrate tablets were non-inferior to sevelamer carbonate in reducing serum phosphorus levels in hyperphosphatemia patients on maintenance hemodialysis, with the added benefit of improving iron-related anemia and a favorable safety profile.

Abstract licence: CC BY