Abstract
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.
Highlights
The rapid ageing of the global population brings forth many noncommunicable diseases, including osteoporosis and its associated fragility fractures
A total of 910 subjects were recruited in the study, but 20 of them were excluded for receiving thiazide diuretics, 32 for glucocorticoids, 4 for cancer treatment, 30 for hormone treatment, 12 for having mobility problems, 5 for hysterectomy before menopause and 21 for not completing study procedure
The current study indicated that the agreement between quantitative ultrasound (QUS) and dual-energy X-ray absorptiometry (DXA) at the current cut-offs was significant but weak
Summary
The rapid ageing of the global population brings forth many noncommunicable diseases, including osteoporosis and its associated fragility fractures. 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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