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Risk of falls in patients with low bone mineral density

Analysis of placebo arms from clinical trials

Sturzrisiko bei Patienten mit niedriger Knochendichte

Analyse von Placeboarmen aus klinischen Studien

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; I2 = 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; I2 = 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.

Zusammenfassung

Einleitung

Stürze stellen einen erhebliche Risikofaktor für osteoporotische Frakturen dar. Aus diesem Grund war das Ziel dieser Studie das Sturzrisiko von Patienten mit niedriger Knochenmineraliendichte („bone mineral density“ [BMD]) und Osteoporose zu analysieren.

Methoden

Zur Bestimmung des Sturzrisikos von Patienten mit niedrigem BMD und/oder Osteoporose wurden Daten aus den Placeboarmen klinischer Studie analysiert, welche unter clinicaltrials.gov gelistet waren. Das Sturzrisiko wurde mittels „Single-arm“-Metaanalyse unter Verwendung eines binären „Random-effects“-Modells ermittelt. Zusätzlich wurden Metaregressionen durchgeführt, zur Identifikation von Assoziationen zwischen Sturzrisiko und Alter, Body Mass Index (BMI) sowie BMD.

Ergebnisse

Insgesamt wurden 8762 Patienten aus Placeboarmen klinischer Studien in diese Analyse mit einbezogen. Bei Patienten mit niedriger BMD und/oder Osteoporose lag das Sturzrisiko bei 5,2 % (0,052 [95 %-Konfidenzintervall [95%-KI]: 0,022; 0,082]; n = 8714; I2 = 97,3 % [p ≤ 0,001]) und bei Patienten mit Osteoporose bei 5,9 % (0,059 [95 %-KI: 0,036; 0,083]; n = 7819; I2 = 87,8 % [p ≤ 0,001]). Signifikante Assoziationen bestanden zwischen dem Sturzrisiko und dem Alter sowie dem BMD an der Gesamthüfte (GH; Koeffizient: −0,077 [95 %-KI: −0,113; −0,040] p ≤ 0,001; n = 7715) und dem Oberschenkelhals (OSH; Koeffizient: −0,044 [95 %-KI: −0,065; −0,023] p ≤ 0,001; n = 7662).

Schlussfolgerung

Diese Analyse konnte das Sturzrisiko bei Patienten mit niedriger BMD oder Osteoporose sowie signifikante Assoziationen des Sturzrisikos mit dem Alter und BMD ermitteln. Aus diesem Grund sollten Patienten mit Osteoporose zwingend sturzrisikominimierende Maßnahmen erhalten, wobei die Knochendichte an GH und OSH möglicherweise als Indikator für das Sturzrisiko fungieren könnte.

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Correspondence to Luis Möckel.

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Conflict of interest

L. Möckel is a former employee of UCB Pharma GmbH and received fees for consulting and presentations from UCB Pharma GmbH.

Ethical standards

For this article no studies with human participants or animals were performed by any of the authors. To the best of the authors knowledge, all studies included into this analysis were performed in accordance with the ethical standards indicated in each case.

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Möckel, L. Risk of falls in patients with low bone mineral density. Z Gerontol Geriat 54, 576–581 (2021). https://doi.org/10.1007/s00391-020-01784-5

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Keywords

  • Osteoporosis
  • Frailty
  • Risk factor for fractures
  • Meta-analysis
  • Predictor of falls

Schlüsselwörter

  • Osteoporose
  • Gebrechlichkeit
  • Fraktur-Risikofaktor
  • Metaanalyse
  • Sturz-Prädiktor