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Nonresponder Considerations for Romosozumab Treatment

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Abstract

Romosozumab can increase bone mineral density (BMD) in patients with osteoporosis, but some patients do not respond to it. This study aimed to identify risk factors for being a nonresponder to romosozumab treatment. This retrospective observational study included 92 patients. Romosozumab (210 mg) was subcutaneously administered to the participants every 4 weeks over 12 months. We excluded patients who previously underwent treatment for osteoporosis to assess the impact of romosozumab alone. We evaluated the proportion of patients who did not respond to romosozumab treatment to the lumbar spine and hip with increased BMD. Nonresponders were defined as those with a bone density change of < 3% after 12 months of treatment. We compared demographics and biochemical markers between responders and nonresponders. We found that 11.5% of patients were nonresponders at the lumbar spine, and 56.8% were nonresponders at the hip. A risk factor for nonresponse at the spine was low type I procollagen N-terminal propeptide (P1NP) values at 1 month. The cutoff value for P1NP at month 1 was 50 ng/ml. We found that 11.5% and 56.8% of patients experienced no significant improvement in the lumbar spine and hip BMD, respectively. Clinicians should use nonresponse risk factors to inform decisions about romosozumab treatment for patients with osteoporosis.

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Acknowledgements

The authors would like to thank Enago (www.enago.com) for the manuscript review and editing support.

Funding

This work was partly supported by a research grant from Tokyo Women’s Medical University Career Development Center for Medical Professionals.

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Authors and Affiliations

  1. Department of Orthopedic Surgery, Tokyo Women’s Medical University, Tokyo, Japan

    Ayako Tominaga, Keiji Wada, Ken Okazaki, Shuji Shimamoto & Yasuteru Kodama

  2. Hasuda Hospital, Saitama, Japan

    Hideharu Nishi & Yasushi Terayama

  3. Kita Shinagawa 3rd Hospital, Tokyo, Japan

    Yoshiharu Kato

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  1. Ayako Tominaga
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  2. Keiji Wada
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Correspondence to Ayako Tominaga.

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Conflict of interest

Ayako Tominaga, Ken Okazaki, Hideharu Nishi, Yasushi Terayama, Shuji Shimamoto, Yasuteru Kodama, and Yoshiharu Kato declare that they have no conflicts of interest. Keiji Wada received a speaking fee from Amgen Inc.

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The procedures complied with the 1964 Helsinki declaration and its later amendments and were approved by Tokyo Women’s Medical University Ethics Committee, number 5596.

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Tominaga, A., Wada, K., Okazaki, K. et al. Nonresponder Considerations for Romosozumab Treatment. Calcif Tissue Int 113, 157–165 (2023). https://doi.org/10.1007/s00223-023-01087-y

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