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Comparison of once-weekly teriparatide and alendronate against new osteoporotic vertebral fractures at week 12

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Abstract

The objective of the present multicenter randomized study was to compare weekly teriparatide with alendronate in their inhibition of vertebral collapse, effects on delayed union, pain relief, and improvement of quality of life (QOL) in women with new osteoporotic vertebral fractures within 1 week after onset of the fracture. Patients were randomly allocated to the teriparatide and alendronate groups. Vertebral collapse, low back pain assessed by a visual analog scale, and QOL assessed by EuroQol 5 dimension at weeks 1, 2, 4, 8, and 12 after the start of the treatment were compared between the groups. Lumbar bone mineral density (BMD) at baseline and week 12 and the rate of delayed union at week 12 were also compared. Each group consisted of 48 subjects. Vertebral collapse progressed over time in both groups, with no significant difference between the groups. Pain on rising up from lying position, turning over in bed, and resting in the lying position improved over time in both groups, with no significant difference between the groups. There were no significant differences in increase in BMD and delayed union. QOL in the teriparatide group showed significant improvement in comparison with that in the alendronate group at week 12. The weekly formulation of teriparatide showed comparable inhibition of vertebral collapse, increase in BMD, promotion of bone union, and improvement of pain and significant improvement of QOL at week 12 in comparison with alendronate in patients with a new osteoporotic vertebral fracture within 1 week after onset of the fracture. The weekly formulation of teriparatide may have improved components of QOL other than pain at week 12.

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Acknowledgements

The authors would like to express their gratitude to the study patients for their participation. The authors would also like to acknowledge the assistance of Kazumasa Tanzawa, EPS Corporation and KOTU T-WRAP study Investigators. The study was funded by the Asahi Kasei Pharma Corporation.

Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, Ken-Ai Memorial Hospital, Onga, Japan

    Satoshi Ikeda

  2. Department of Orthopaedic Surgery, University of Occupational and Environmental Health, Kitakyushu, Japan

    Eiichiro Nakamura & Akinori Sakai

  3. Department of Orthopaedic Surgery, Nakashibetsu Town Hospital, Nakashibetsu, Japan

    Kenichiro Narusawa

  4. Department of Orthopaedic Surgery, Kitakyushu General Hospital, Kitakyushu, Japan

    Fumio Fukuda

  5. Department of Orthopaedic Surgery, Sanzai Hospital, Miyazaki, Japan

    Hidehiro Matsumoto

  6. Department of Orthopaedic Surgery, Moriguchi Ikuno Memorial Hospital, Moriguchi, Japan

    Kenichiro Nakai

  7. Department of Orthopaedic Surgery, Kitade Hospital, Gobo, Japan

    Takeshi Sakata

  8. Department of Orthopaedic Surgery, Shimura Hospital, Hiroshima, Japan

    Toru Yoshioka

  9. Department of Environmental Epidemiology, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Kitakyusyu, Japan

    Yoshihisa Fujino

Authors
  1. Satoshi Ikeda
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  2. Eiichiro Nakamura
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  3. Kenichiro Narusawa
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  4. Fumio Fukuda
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  5. Hidehiro Matsumoto
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  6. Kenichiro Nakai
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  7. Takeshi Sakata
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  8. Toru Yoshioka
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  9. Yoshihisa Fujino
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  10. Akinori Sakai
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Consortia

KOTU T-WRAP Study Investigators

Contributions

SI designed the study and wrote the initial draft of the manuscript. Other authors have contributed to data collection and interpretation, and critically reviewed the manuscript. All authors contributed to analysis and interpretation of data, approved the final version of the manuscript, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Satoshi Ikeda.

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Conflict of interest

S. Ikeda has received payments for lectures, including speakers’ bureau fees, from Chugai Pharmaceutical Co., Ltd, Daiichi-Sankyo Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., and Teijin Pharma Ltd. A Sakai has received lecture fee from Asahi Kasei Pharma Corporation and Chugai Pharmaceutical Co., Ltd. E Nakamura, K Narusawa, F Fukuda, H Matsumoto, K Nakai, T Sakata, T Yoshioka, and Y Fujino declare that they have no conflict of interest.

Ethical approval

The study protocol and associated documents used in this study were reviewed and approved by the internal review board at each study site in accordance with the Declaration of Helsinki. All procedures in this study involving human participants were performed in accordance with the ethical standards of the institutional and/or national research committee and with the Declaration of Helsinki and its later amendments or comparable ethical standards.

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Written informed consent was obtained from all individual participants included in this study before initiating any procedures.

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Ikeda, S., Nakamura, E., Narusawa, K. et al. Comparison of once-weekly teriparatide and alendronate against new osteoporotic vertebral fractures at week 12. J Bone Miner Metab 38, 44–53 (2020). https://doi.org/10.1007/s00774-019-01023-x

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  • DOI: https://doi.org/10.1007/s00774-019-01023-x

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