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评价口服柠檬酸钙在老年骨质减少症患者中的依从性、耐受性和安全性:一项真实世界的、非干预性、前瞻性、多中心研究。

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

机构信息

Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Via Forlanini, 2, 27100, Pavia, Italy.

Department of Clinical, Internal, Anesthesiological and Cardiological Sciences, "Sapienza" University of Rome, Rome, Italy.

出版信息

Aging Clin Exp Res. 2024 Feb 12;36(1):38. doi: 10.1007/s40520-024-02696-9.

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.

摘要

背景

骨质疏松症是老年人常见的问题,会导致骨骼脆弱。补钙对于改善骨骼健康、降低骨折风险以及支持这一脆弱人群的整体骨骼强度至关重要。然而,关于老年人补充钙剂的安全性存在相互矛盾的证据。

目的

本研究旨在评估柠檬酸钙补充剂在老年骨质疏松症患者中的依从性、安全性和耐受性。

方法

在这项非干预性、前瞻性、多中心研究中,受试者每天接受 500mg 柠檬酸钙补充剂治疗,为期一年。依从性基于依从性和持久性进行计算。安全性通过不良反应(ARs)、死亡和临床实验室评估进行评估。

结果

共有 268 名白种人受试者(91.4%为女性,平均年龄 70±4.5 岁)参与了这项研究。治疗的平均依从率为 76.6±29.5%,一半的受试者依从率为 91%,~33%的受试者达到完全(100%)依从。9 名(3.9%)受试者报告了 ARs,主要为胃肠道疾病,无严重 ARs。依从性<80%的受试者(41.6%;77/185)发生所有不良事件(包括 ARs)的频率明显高于依从性≥80%的受试者(11%;145/1304,p<0.0001)。与基线相比,收缩压和舒张压在随访时均下降(变化分别为-2.8±13.9mmHg,p=0.0102 和-2.1±10.4mmHg,p=0.0116)。

结论

本研究表明,老年骨质疏松症患者对柠檬酸钙补充剂的依从性良好。尽管 ARs 通常较轻,但它们与钙补充剂的低依从性有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ef1/10861607/270bbd319153/40520_2024_2696_Fig1_HTML.jpg

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