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Twice-weekly teriparatide improves lumbar spine BMD independent of pre-treatment BMD and bone turnover marker levels

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Journal of Bone and Mineral Metabolism Aims and scope Submit manuscript

Abstract

Introduction

There have been no reports of the effects of baseline lumbar spine bone mineral density (LS-BMD) and bone turnover marker levels on the therapeutic effect of a 28.2-μg teriparatide formulation for twice-weekly use (2/W-TPTD).

Materials and methods

An analysis was performed using data from a double-blind, randomized, non-inferiority trial (TWICE study) conducted with patients who received 2/W-TPTD or a 56.5-μg teriparatide formulation for once-weekly use (1/W-TPTD) for 48 weeks. The patients were divided into tertile groups based on baseline LS-BMD, urinary type I collagen cross-linked N-telopeptide (u-NTX), and serum type I procollagen-N-propeptide (P1NP) levels, respectively. Time profiles of these measurements were analyzed. Furthermore, whether a change in P1NP is a predictor for percentage change in BMD was assessed.

Results

Across all tertile groups divided based on baseline LS-BMD and levels of bone turnover markers, the LS-BMD increased significantly. The u-NTX level decreased throughout the study period in the high- and middle-u-NTX-level groups. The P1NP level increased after 4 weeks, but subsequently decreased after 12 weeks and thereafter in the high-P1NP-level group; it increased after 4 weeks and subsequently fluctuated near the baseline level in the middle-P1NP-level group. A cut-off value of 12.0 µg/L for change in P1NP after 4 weeks of 2/W-TPTD as a predictor for percentage change in LS-BMD of 3% or more after 48 weeks gave a positive predictive value of 89.6%.

Conclusion

2/W-TPTD, just like 1/W-TPTD, improved LS-BMD significantly, regardless of baseline LS-BMD and bone turnover marker levels.

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Acknowledgements

The authors would like to thank the investigators and clinical sites in Japan that participated in this study.

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Authors and Affiliations

  1. Osteoporosis Center, Sapporo Kotoni Orthopaedics, 4-1-30 Kotoni-4-Jou, Sapporo, Hokkaido, Japan

    Junichi Takada

  2. Medical Affairs Department, Asahi-Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

    Takeshi Yoshimura & Toyonobu Uzawa

Authors
  1. Junichi Takada
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  2. Takeshi Yoshimura
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  3. Toyonobu Uzawa
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Contributions

JT original study design, formal analysis, writing—original draft. TY formal analysis, writing—original draft. TU formal analysis, writing—original draft.

Corresponding author

Correspondence to Junichi Takada.

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Conflict of interest

JT received lecture and advisor fees from Asahi Kasei Pharma. TY and TU are employees of Asahi Kasei Pharma Corporation. The study was sponsored and funded by Asahi Kasei Pharma Corporation, Tokyo, Japan. The sponsor had responsibility for quality control. The corresponding author had full access to all of the data in the study and had responsibility for the decision to submit for publication. The study was jointly designed by the authors and the sponsor, Asahi Kasei Pharma Corporation. The authors discussed the interpretation of the data and the conclusions of the manuscript with the sponsor. Data analyses for publication were the responsibilities of the sponsor.

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Takada, J., Yoshimura, T. & Uzawa, T. Twice-weekly teriparatide improves lumbar spine BMD independent of pre-treatment BMD and bone turnover marker levels. J Bone Miner Metab 39, 484–493 (2021). https://doi.org/10.1007/s00774-020-01186-y

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  • DOI: https://doi.org/10.1007/s00774-020-01186-y

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