Department of Movement, Human and Health Sciences, Health Sciences Section, University Foro Italico of Rome, 00135 Rome, Italy.
Department of Theoretical and Applied Sciences, eCampus University, 22060 Novedrate, Italy.
Int J Environ Res Public Health. 2021 Feb 10;18(4):1728. doi: 10.3390/ijerph18041728.
Denosumab is a human monoclonal antibody that neutralizes RANKL, a cytokine able to interact with the RANK receptor on preosteoclasts and osteoclasts, decreasing their recruitment and differentiation, leading to a decreased bone resorption. The aim of this observational real-life study was to analyze adherence to denosumab therapy and assess its efficacy in increasing bone mineral density (BMD) and modulating biochemical skeletal markers following previous treatments with bisphosphonates in a group of post-menopausal women with osteoporosis. Women were recruited in the specialized center from March 2012 to September 2019. Biochemical markers were recorded at baseline and every six months prior to subsequent drug injection. Dual X-ray absorptiometry was requested at baseline and after 18/24 months. Comparing BMD at baseline and after denosumab therapy in naive patients and in those previously treated with bisphosphonates, a positive therapeutic effect was observed in both groups. The results of our real-life study demonstrate, as expected, that BMD values significantly increased upon denosumab treatment. Interestingly, denosumab showed an increased efficacy in patients previously treated with bisphosphonates. Moreover, biochemical markers data indicate that osteoporotic patients, without other concomitant unstable health conditions, could be evaluated once a year, decreasing the number of specialistic center access.
地舒单抗是一种人源化单克隆抗体，能中和核因子-κB 受体活化因子配体（RANKL），RANKL 能与破骨细胞前体细胞和破骨细胞上的 RANK 受体相互作用，减少其募集和分化，从而降低骨吸收。本观察性真实世界研究的目的是分析地舒单抗治疗的依从性，并评估其在一组绝经后骨质疏松女性中增加骨密度（BMD）和调节生化骨骼标志物的疗效，这些女性先前接受过双膦酸盐治疗。女性于 2012 年 3 月至 2019 年 9 月在专门中心招募。在随后的药物注射前，每 6 个月记录一次生化标志物。在基线和 18/24 个月后要求进行双能 X 线吸收法骨密度检查。比较初治患者和先前接受双膦酸盐治疗患者的基线和地舒单抗治疗后的 BMD，两组均观察到治疗的积极效果。我们的真实世界研究结果表明，正如预期的那样，地舒单抗治疗后 BMD 值显著增加。有趣的是，地舒单抗在先前接受双膦酸盐治疗的患者中显示出更高的疗效。此外，生化标志物数据表明，没有其他伴随不稳定健康状况的骨质疏松患者可以每年评估一次，减少专科中心就诊次数。
