Effect of denosumab treatment on bone mineral density and bone turnover markers in osteoporotic patients: real-life experience 2-year follow-up,Archives of Osteoporosis

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Effect of denosumab treatment on bone mineral density and bone turnover markers in osteoporotic patients: real-life experience 2-year follow-up
Archives of Osteoporosis ( IF 3.1 ) Pub Date : 2022-09-17 , DOI: 10.1007/s11657-022-01145-2
Ceyda Dincer Yazan ₁ , Onur Bugdayci ₂ , Can Ilgin ₃ , Dilek Gogas Yavuz ₁

Affiliation

Summary

Denosumab leads to improvements in BMD levels and is a well-tolerated agent according to results of randomized controlled studies but results in real-life setting are important to evaluate drug adherence and real-life efficiency. In this study, we present the results of 305 patients that were treated with denosumab in our clinic.

Introduction

The long-term efficacy of anti-osteoclastic drugs in treatment of osteoporosis is well known. Denosumab, a novel human monoclonal antibody, is an anti-osteoclastic agent that has been shown to lead to reductions in vertebral, nonvertebral, and hip fracture risk in randomized and observational studies. Real-life data of this agent is increasing. In this study, we presented our real-life data about the 2-year follow-up of patients under denosumab treatment.

Methods

Osteoporotic patients who were treated with at least one denosumab injection between 2014 and 2020 years were included. Clinical and demographic data, bone turnover markers, and radiological reports (bone mineral densitometry (BMD), vertebral x-ray) were obtained from patient files retrospectively.

Results

A total of 305 patients (f/m: 275/30, 68.1 ± 11.05 years) were included. The median injection number was 4 (1–10). Two hundred seventy-three patients (89.8%) were persistent on treatment at the 12th month; 175 patients (57.3%) were persistent at 24th month. Sixty-eight patients (22%) were not using denosumab anymore, 55 of the patients were not continuing by doctor desicion and 13 were not continuing due to patient-related causes. Median BMD levels significantly increased from 0.809 (0.2–1.601, IQR: 0.136) to 0.861 (0.517–1.607, IQR: 0.14) in L1–L4 and from 0.702 (0.349–0.997, IQR: 0.125) to 0.745 (0.508–1.008, IQR: 0.137) in femur area at the 24th month of treatment. An improvement of 8.04% in L1–L4 BMD and 4.5% in femur neck BMD levels at the 24th month of treatment was observed. There was a significant decrease in bone turnover markers at the 24th month of treatment.

Conclusion

In our group of patients under denosumab treatment, 53% of persistence was found at 24 months and associated with improvement in BMD levels without any significant side effects except one case with urticarial reaction. Denosumab leads to improvements in BMD levels and is a well-tolerated agent in a real-life setting comparable to results of randomized controlled studies in patients with different comorbidities.

中文翻译：

狄诺塞麦治疗对骨质疏松症患者骨密度和骨转换标志物的影响：真实生活经验 2 年随访

概括

根据随机对照研究的结果，狄诺塞麦可改善 BMD 水平并且是一种耐受性良好的药物，但现实生活中的结果对于评估药物依从性和现实生活效率很重要。在这项研究中，我们展示了 305 名在我们诊所接受地诺单抗治疗的患者的结果。

介绍

抗破骨药物治疗骨质疏松症的长期疗效是众所周知的。Denosumab 是一种新型人类单克隆抗体，是一种抗破骨剂，在随机和观察性研究中已被证明可以降低椎骨、非椎骨和髋部骨折的风险。该代理的真实数据正在增加。在这项研究中，我们展示了我们对接受狄诺塞麦治疗的患者进行为期 2 年随访的真实数据。

方法

纳入了在 2014 年至 2020 年间至少接受过一次地诺单抗注射治疗的骨质疏松症患者。回顾性地从患者档案中获得临床和人口统计学数据、骨转换标志物和放射学报告（骨矿物质密度测定法 (BMD)、椎骨 X 射线）。

结果

总共包括 305 名患者（f/m：275/30，68.1 ± 11.05 岁）。中位注射次数为 4 (1–10)。273 名患者 (89.8%) 在第 12 个月时坚持治疗；175 名患者 (57.3%) 在第 24 个月时持续存在。68 名患者 (22%) 不再使用狄诺塞麦，其中 55 名患者因医生决定不再继续使用，13 名患者由于与患者相关的原因而不再继续使用。L1-L4 的中位 BMD 水平从 0.809（0.2-1.601，IQR：0.136）显着增加到 0.861（0.517-1.607，IQR：0.14），从 0.702（0.349-0.997，IQR：0.125）显着增加到 0.745（0.508-1.008， IQR：0.137) 在治疗第 24 个月时股骨区域。在治疗的第 24 个月观察到 L1-L4 BMD 改善了 8.04%，股骨颈 BMD 水平改善了 4.5%。