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Efficacy of denosumab on bisphosphonate-treated osteoporosis and osteopenia in systemic rheumatic disease patients receiving glucocorticoids

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Abstract

Introduction

Evidence on second-line agents for osteoporosis and osteopenia associated with glucocorticoid use after first-line bisphosphonate therapy is limited. We, therefore, examine the efficacy of denosumab on bisphosphonate-treated osteoporosis and osteopenia in Japanese systemic rheumatic disease (SRD) patients receiving glucocorticoids.

Materials and methods

Glucocorticoid-treated SRD patients with a pre-existing fragility fracture, either lumbar spine (LS) or femoral neck (FN) bone mineral density (BMD) T-score of ≤ −2.5 or of ≤ −1.5 without a significant increase in BMD in the past year despite oral bisphosphonate therapy were enrolled in this study. They were randomized to switch to 60 mg subcutaneous denosumab every six months (switching group) or to continue the bisphosphonate (continuing group). The primary endpoint was the percent change from baseline in BMD at the LS and FN at week 52.

Results

Of the 39 subjects, 19 were assigned to the switching group and 20 to the continuing group. The switching group showed significant increases in LS BMD (5.7% vs. 1.1%, p = 0.002) and FN BMD (4.2% vs. −0.3%, p = 0.008) at week 52 than the continuing group, with a significant decrease in serum tartrate-resistant acid phosphatase 5b (−28.1% vs. 7.0%, p < 0.001) and improved patient satisfaction.

Conclusion

Switching to denosumab demonstrated greater efficacy than continuing bisphosphonates in increasing BMD, inhibiting osteoclast activation, and enhancing patient satisfaction in Japanese bisphosphonate-treated osteoporosis and osteopenia patients with concomitant SRD receiving glucocorticoids.

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Data availability

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

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Acknowledgements

The authors would like to thank Drs. Shiho Iwagaitsu, Department of Nephrology and Rheumatology, Aichi Medical University Hospital, who cared for the patients, and Prof. Akio Niimi, Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, who provided general support as a department chair.

Funding

None declared.

Author information

Authors and Affiliations

  1. Division of Rheumatology, Department of Internal Medicine, Nagoya City University Hospital, Nagoya, Aichi, Japan

    Shin-ya Tamechika, Shinji Maeda & Taio Naniwa

  2. Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Kawasumi, Mizuho-Ku, Nagoya, Aichi, 467-8601, Japan

    Shin-ya Tamechika, Shinji Maeda & Taio Naniwa

  3. Department of Rheumatology, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan

    Shin-ichiro Ohmura

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  1. Shin-ya Tamechika
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Contributions

Study design: SO and TN. Study conduct and data collection: SO, ST, and TN. Data analysis: ST and TN. Data interpretation: ST and TN. The first draft of the manuscript: ST and TN. Revising manuscript content: ST and TN with assistance in the form of critique and suggestions from all authors. Approving final version of manuscript: all authors. TN takes responsibility for the integrity of the data analysis.

Corresponding author

Correspondence to Taio Naniwa.

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Conflict of interest

T.N. received grants from Chugai Pharmaceutical Co., Ltd, speaker fees from Chugai Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd, Eisai Co., Ltd, and Astellas Pharma Inc. S.T. received speaker fees from Chugai Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd, Eisai Co., Ltd, Daiichi-Sankyo Co., Ltd., and Astellas Pharma Inc. S.O. received speaker fees from Chugai Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd, Daiichi-Sankyo Co., Ltd., and Astellas Pharma Inc. S.M. received speaker fees from Ono Pharmaceutical Co., Ltd.

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Tamechika, Sy., Ohmura, Si., Maeda, S. et al. Efficacy of denosumab on bisphosphonate-treated osteoporosis and osteopenia in systemic rheumatic disease patients receiving glucocorticoids. J Bone Miner Metab 41, 203–211 (2023). https://doi.org/10.1007/s00774-022-01393-9

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  • DOI: https://doi.org/10.1007/s00774-022-01393-9

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