Diagnostics (Mar 2020)

The Performance of a Calcaneal Quantitative Ultrasound Device, CM-200, in Stratifying Osteoporosis Risk among Malaysian Population Aged 40 Years and Above

  • Shaanthana Subramaniam,
  • Chin-Yi Chan,
  • Ima Nirwana Soelaiman,
  • Norazlina Mohamed,
  • Norliza Muhammad,
  • Fairus Ahmad,
  • Pei-Yuen Ng,
  • Nor Aini Jamil,
  • Noorazah Abd Aziz,
  • Kok-Yong Chin

DOI
https://doi.org/10.3390/diagnostics10040178
Journal volume & issue
Vol. 10, no. 4
p. 178

Abstract

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Background: Calcaneal quantitative ultrasound (QUS) is widely used in osteoporosis screening, but the cut-off values for risk stratification remain unclear. This study validates the performance of a calcaneal QUS device (CM-200) using dual-energy X-ray absorptiometry (DXA) as the reference and establishes a new set of cut-off values for CM-200 in identifying subjects with osteoporosis. Methods: The bone health status of Malaysians aged ≥40 years was assessed using CM-200 and DXA. Sensitivity, specificity, area under the curve (AUC) and the optimal cut-off values for risk stratification of CM-200 were determined using receiver operating characteristic (ROC) curves and Youden’s index (J). Results: From the data of 786 subjects, CM-200 (QUS T-score <−1) showed a sensitivity of 82.1% (95% CI: 77.9−85.7%), specificity of 51.5% (95% CI: 46.5−56.6%) and AUC of 0.668 (95% CI: 0.630−0.706) in identifying subjects with suboptimal bone health (DXA T-score <−1) (p < 0.001). At QUS T-score ≤−2.5, CM-200 was ineffective in identifying subjects with osteoporosis (DXA T-score ≤−2.5) (sensitivity 14.4% (95% CI: 8.1−23.0%); specificity 96.1% (95% CI: 94.4−97.4%); AUC 0.553 (95% CI: 0.488−0.617); p > 0.05). Modified cut-off values for the QUS T-score improved the performance of CM-200 in identifying subjects with osteopenia (sensitivity 67.7% (95% CI: 62.8−72.3%); specificity 72.8% (95% CI: 68.1−77.2%); J = 0.405; AUC 0.702 (95% CI: 0.666−0.739); p < 0.001) and osteoporosis (sensitivity 79.4% (95% CI: 70.0−86.9%); specificity 61.8% (95% CI: 58.1−65.5%); J = 0.412; AUC 0.706 (95% CI: 0.654−0.758); p < 0.001). Conclusion: The modified cut-off values significantly improved the performance of CM-200 in identifying individuals with osteoporosis. Since these values are device-specific, optimization is necessary for accurate detection of individuals at risk for osteoporosis using QUS.

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