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Early adverse events after the first administration of zoledronic acid in Japanese patients with osteoporosis

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Abstract

Introduction

The occurrence of early adverse events and the factors associated with these events in zoledronic acid-treated Japanese patients with osteoporosis were investigated.

Materials and methods

All patients treated with zoledronic acid for the first time for primary osteoporosis were analyzed. Based on the history of bisphosphonate (BP) administration, the patients were divided into three groups: BP-switch, BP-washout, and naïve groups. The BP-washout and naive groups were combined into a non-BP group.

Results

A total of 184 patients with a mean age of 77.4 years were included. Acute phase reactions (APRs) occurred in 32 patients (17.4%). The significant risk factors were hospitalization (vs. outpatients), BP-switch (vs. non-BP), and age > 80 years (vs. ≤ 69 years), and the odds ratios were 5.63, 0.12, and 0.23, respectively. The serum calcium levels were significantly reduced in the non-BP group, regardless of the co-administration of active vitamin D3. However, the patients who were co-administered active vitamin D3 had significantly higher values than those who were not. In the BP-switch group, no significant reduction in serum calcium levels was observed; however, the reductions tended to be smaller in the patients who were co-administered active vitamin D3.

Conclusion

Occurrence of APRs might be lesser in clinical practice than in phase 3 clinical trials. Although serum calcium levels decreased in many cases, the decrease could be suppressed by the co-administration of active vitamin D3.

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Acknowledgements

This research was supported by the Asahi Kasei Pharma Corporation.

Author information

Authors and Affiliations

  1. Osteoporosis Center, Sapporo Kotoni Orthopaedic, 1-30 Kotoni 4-4, Nishi-ku, Sapporo, Hokkaido, 063-0814, Japan

    Junichi Takada & Tomohiro Akatsuka

  2. Health Sciences University of Hokkaido Hospital, Ainosato 2-5, Kita-ku, Sapporo, Hokkaido, 002-8072, Japan

    Junichi Takada

  3. Department of Orthopaedic Surgery, Sapporo Medical University, S-1, W-16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan

    Junichi Takada, Kousuke Iba, Akira Saito & Toshihiko Yamashita

  4. Ebetsu Yamamoto Orthopedics, 3-3, Takasago-cho, Ebetsu, Hokkaido, 067-0074, Japan

    Osamu Yamamoto

  5. Do-Clinic Orthopaedic/Musculoskeletal Rehabilitaion, 291-81, S-1, W-14, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan

    Takayuki Dohke

  6. Department of Orthopaedic Surgery, Chitose City Hospital, 2-1-1, Hokko, Chitose, Hokkaido, 066-8550, Japan

    Akira Saito

  7. Sapporo Maruyama Orthopedic Hospital, 1-3, N-7, W-27, Chuo-ku, Sapporo, Hokkaido, 060-0007, Japan

    Megumu Yamamura & Tsuneo Takebayashi

Authors
  1. Junichi Takada
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  2. Kousuke Iba
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  3. Osamu Yamamoto
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  4. Takayuki Dohke
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  5. Akira Saito
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  6. Megumu Yamamura
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  7. Tsuneo Takebayashi
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  8. Tomohiro Akatsuka
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  9. Toshihiko Yamashita
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Contributions

JT and KI designed the study, performed formal analysis, and wrote the original draft. JT, KI, OY, TD, and AS collected the data. JT, KI, MY, TT, and TA analyzed the data. JT, KI, and TY edited the final manuscript. All authors read and approved drafts of the manuscript.

Corresponding author

Correspondence to Junichi Takada.

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Conflict of interest

JT received lecture and advisor fees from Asahi Kasei Pharma Corporation. The other authors have no conflicts of interest to declare.

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Takada, J., Iba, K., Yamamoto, O. et al. Early adverse events after the first administration of zoledronic acid in Japanese patients with osteoporosis. J Bone Miner Metab 39, 903–910 (2021). https://doi.org/10.1007/s00774-021-01231-4

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  • DOI: https://doi.org/10.1007/s00774-021-01231-4

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