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Predicting the acute-phase response fever risk in bisphosphonate-naive osteoporotic patients receiving their first dose of zoledronate

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Abstract

Introduction

To devise a precise and efficient tool for predicting the individualized risk of acute-phase response (APR) in bisphosphonate (BP)-naive osteoporotic (OP) patients, receiving their first intravenous dose of zoledronate (ZOL).

Methods

The baseline clinical and laboratory data of 475 consecutive BP-naive OP patients, who received their first intravenous dose of ZOL between March 2016 and March 2021 in the Affiliated Kunshan Hospital of Jiangsu University, were chosen for analysis. Univariate and multivariable logistic regression models were generated to establish candidate predictors of APR fever risk, using three distinct fever thresholds, namely, 37.3 °C (model A), 38.0 °C (model B), and 38.5 °C (model C). Next, using predictor regression coefficients, three fever-threshold nomograms were developed. Discrimination, calibration, and clinical usefulness of each predicting models were then assessed using the area under the curve (AUC), calibration curve (CC), and decision curve analysis (DCA). The internal and external model validations were then performed.

Results

The stable predictors were age, serum 25-hydroxy vitamin D, serum total calcium, and peripheral blood erythrocytes count. These were negatively associated with the APR fever risk. The AUCs of models A, B, and C were 0.828 (95% confidence intervals [CI], 0.782 to 0.874), 0.825 (95% CI, 0.767 to 0.883), and 0.879 (95% CI, 0.824 to 0.934), respectively. Good agreement was observed between the predictions and observations in the CCs of all three nomograms.

Conclusions

This study developed and validated nomogram prediction models that can predict APR fever risk in BP-naive OP patients receiving their first infusion of ZOL.

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Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Funding

The study was supported by the National Natural Science Foundation of China (CN) (82172441), Scientific Research Project of Gusu School of Nanjing Medical University (CN) (GSKY20210244), Clinical Medical Science and Technology Development Fund of Jiangsu University (CN) (JLY2021048), and Suzhou Key Clinical Diagnosis and Treatment Technology Project (CN) (LCZX202024).

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Authors and Affiliations

  1. Department of Orthopedics, Affiliated Kunshan Hospital of Jiangsu University, Gusu School, Nanjing Medical University, No. 91 West of Qianjin Road, Suzhou, 215300, Jiangsu, China

    Ke Lu & Chong Li

  2. Department of Orthopedics, the First Affiliated Hospital of Soochow University, Orthopedic Institute of Soochow University, Suzhou, 215031, Jiangsu, China

    Qin Shi

  3. Information Department, Affiliated Kunshan Hospital of Jiangsu University, Gusu School, Nanjing Medical University, Suzhou, 215300, Jiangsu, China

    Ya-qin Gong

  4. Product R & D Department, Shanghai Fosun Health Technology Group Co Ltd, Shanghai, 200030, China

    Jia-wei Shao

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  1. Ke Lu
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  5. Chong Li
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Contributions

Ke Lu: Wrote the manuscript. Collected and analyzed the data. Qin Shi: Designed the study. Ya-qin Gong: collected and managed the data. Jia-wei Shao: collected and analyzed the data. Chong Li: designed the study.

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Correspondence to Chong Li.

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Ethics approval and consent to participate

This is a retrospective observational study, based on medical data from a clinical registry. This work is registered in the Chinese Clinical Trial Registry (ChiCTR2000036375). In addition, we received ethical approval from the Affiliated Kunshan Hospital of Jiangsu University (approval No. 2020–03-046-K01), and the study was compliant with the Declaration of Helsinki. All participants provided written informed consent for participation and data collection.

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Lu, K., Shi, Q., Gong, Yq. et al. Predicting the acute-phase response fever risk in bisphosphonate-naive osteoporotic patients receiving their first dose of zoledronate. Osteoporos Int 33, 2381–2396 (2022). https://doi.org/10.1007/s00198-022-06493-w

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