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低骨密度患者的跌倒风险:临床试验安慰剂组分析。

Risk of falls in patients with low bone mineral density : Analysis of placebo arms from clinical trials.

机构信息

HSD Hochschule Döpfer, University of Applied Sciences Cologne, Waidmarkt 3 & 9, 50676, Cologne, Germany.

出版信息

Z Gerontol Geriatr. 2021 Oct;54(6):576-581. doi: 10.1007/s00391-020-01784-5. Epub 2020 Sep 23.

DOI:10.1007/s00391-020-01784-5
PMID:32965541
Abstract

BACKGROUND

Falls are a major risk factor for osteoporotic fractures. Therefore, the aim of this study was to analyze the risk of falls in patients with low bone mineral density (BMD) and osteoporosis.

METHODS

The risk of falls in patients with low BMD and/or osteoporosis was analyzed using data from placebo arms of clinical trials, indexed on clinicaltrials.gov. The risk was estimated using a single arm meta-analysis method and by applying a binary random effects model. In addition, meta-regression analyses were performed to identify associations between risk of falls and age, body mass index (BMI) and BMD.

RESULTS

A total of 8762 patients from placebo arms of clinical trials were included into the analysis. Risk of falls was 5.2% (0.052, 95% confidence interval [95% CI] 0.022-0.082; n = 8714; I = 97.3%, p ≤ 0.001) in patients with low BMD and/or osteoporosis and 5.9% (0.059, 95% CI 0.036-0.083; n = 7819; I = 87.8%, p ≤ 0.001) in patients with osteoporosis. A significant association with risk of falls was identified for age in patients with low BMD and/or osteoporosis. BMD at total hip (TH; coefficient -0.077, 95% CI: -0.113--0.040, p ≤ 0.001; n = 7715) and femoral neck (FN; coefficient -0.044, 95% CI -0.065--0.023, p ≤ 0.001; n = 7662) were significantly associated with risk of falls in patients with osteoporosis.

CONCLUSION

This analysis identified the risk of falls in patients with low BMD and osteoporosis and an association of falls with age and BMD. Therefore, patients with osteoporosis need to receive mandatory fall risk mitigation measures, and the BMD at total hip or femoral neck could function as an indicator for the risk of falling.

摘要

背景

跌倒 是骨质疏松性骨折的一个主要危险因素。因此,本研究旨在分析低骨密度(BMD)和骨质疏松症患者的跌倒风险。

方法

使用clinicaltrials.gov 索引的临床试验安慰剂臂的数据,分析低 BMD 和/或骨质疏松症患者的跌倒风险。使用单臂荟萃分析方法和二项随机效应模型估计风险。此外,进行了荟萃回归分析以确定跌倒风险与年龄、体重指数(BMI)和 BMD 之间的关联。

结果

共纳入 8762 名来自临床试验安慰剂臂的患者进行分析。低 BMD 和/或骨质疏松症患者的跌倒风险为 5.2%(0.052,95%置信区间 [95%CI] 0.022-0.082;n=8714;I=97.3%,p≤0.001),骨质疏松症患者的跌倒风险为 5.9%(0.059,95%CI 0.036-0.083;n=7819;I=87.8%,p≤0.001)。在低 BMD 和/或骨质疏松症患者中,年龄与跌倒风险显著相关。在骨质疏松症患者中,全髋关节(TH)BMD(系数-0.077,95%CI:-0.113--0.040,p≤0.001;n=7715)和股骨颈(FN)BMD(系数-0.044,95%CI -0.065--0.023,p≤0.001;n=7662)与跌倒风险显著相关。

结论

本分析确定了低 BMD 和骨质疏松症患者的跌倒风险,以及跌倒与年龄和 BMD 的关联。因此,骨质疏松症患者需要接受强制性的跌倒风险缓解措施,而全髋关节或股骨颈的 BMD 可作为跌倒风险的指标。

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