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Eldecalcitol reduces the risk of severe vertebral fractures and improves the health-related quality of life in patients with osteoporosis

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Abstract

Eldecalcitol reduces the risk of vertebral fractures in comparison to alfacalcidol in osteoporotic patients under vitamin D repletion. The aim of this study was to evaluate the effects of eldecalcitol on the spinal location of incident vertebral fractures, the severity of the fractures, and the changes in health-related quality of life (HRQOL) compared with those of alfacalcidol. The post hoc analysis has been performed on the data from the three-year, double-blind, randomized, head-to-head clinical trial of eldecalcitol versus alfacalcidol conducted in Japan. A total of 1054 patients were enrolled and randomized to take 0.75 μg eldecalcitol or 1.0 μg alfacalcidol daily for 3 years. The incidence of vertebral fractures was re-evaluated based on the location on the spine (upper T4–T10; lower T11–L4). The severity of vertebral fractures was determined by the semi-quantitative method, and the change in HRQOL was analyzed by using the Medical Outcomes Study Short Form 36-item questionnaire. The incidence of vertebral fracture at the lower spine was less in the eldecalcitol group than in the alfacalcidol group (p = 0.029). The incidence of severe vertebral fracture (Grade 3) was 3.8 % in the eldecalcitol group and 6.7 % in the alfacalcidol group, demonstrated a significant difference between the 2 groups (p = 0.036). Both eldecalcitol and alfacalcidol improved HRQOL in osteoporotic patients. Although no significant differences in each HRQOL scores were observed between eldecalcitol and alfacalcidol during the observational period, overall improvement from baseline of HRQOL scores were clearly observed in the eldecalcitol group. In conclusion, the incidences of lower spinal vertebral fractures and severe vertebral fractures were reduced further by eldecalcitol compared to alfacalcidol in the 3-year clinical trial. Daily treatment with eldecalcitol is effective in improving HRQOL, possibly owing to the reduced risk of lower spinal vertebral fractures and/or severe vertebral fractures.

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Acknowledgments

The present study was sponsored by Chugai Pharmaceutical Co., Ltd. The sponsor of the study participated in the design of the study, data collection, data analyses, data interpretation, and writing of the report. The sponsor supplied the study medication and had responsibility for data collection and quality control. The corresponding author had full access to all the data in the study and had responsibility for the decision to submit for publication. The authors thank all the investigators who participated in the eldecalcitol phase III clinical trial.

Conflict of interest

H. Hagino is a member of an advisory board (Asahi Kasei Pharma, Eli Lilly, Japan) and has received research grants and/or consulting fees (Asahi Kasei Pharma, Astellas, Chugai, Eisai, Eli Lilly, Japan, Mitsubishi Tanabe Pharma, MSD, Ono, Pfizer Japan, Taisho Toyama, Takeda, Teijin Pharma). T. Takano is a fulltime employee of Chugai Pharmaceutical Co., Ltd. M. Fukunaga is a member of an advisory council (Asahi Kasei Pharma, Astellas). M. Shiraki has received consulting fees (Asahi Kasei Pharma, Astellas, Chugai, Daiichi Sankyo, MSD, Teijin Pharma) and lecture fees (Eisai, Ono). T. Nakamura has received research grants and/or consulting fees (Asahi Kasei Pharma, Astellas, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, MSD, Ono, Takeda, Teijin Pharma) and belongs to the Japan Ministry of Health, Welfare and Labor as a councilor for hospital administration and social medical insurance. T. Matsumoto is a member of an advisory board (Lilly) and has received consulting fees (Asahi Kasei Pharma, Astellas, Chugai, Daiichi Sankyo, Ono, Teijin Pharma).

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Authors and Affiliations

  1. School of Health Science, Tottori University, 86 Nishi-Cho, Yonago, Tottori, 683-8503, Japan

    Hiroshi Hagino

  2. Chugai Pharmaceutical Co. Ltd, Tokyo, 103-8324, Japan

    Toshiyuki Takano

  3. Kawasaki Medical School, Okayama, 701-0192, Japan

    Masao Fukunaga

  4. Research Institute and Practice for Involutional Diseases, Nagano, 399-8101, Japan

    Masataka Shiraki

  5. University of Occupational and Environmental Health, Fukuoka, 807-8555, Japan

    Toshitaka Nakamura

  6. University of Tokushima Graduate School of Medical Sciences, Tokushima, 770-8503, Japan

    Toshio Matsumoto

Authors
  1. Hiroshi Hagino
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  2. Toshiyuki Takano
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  3. Masao Fukunaga
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  4. Masataka Shiraki
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  5. Toshitaka Nakamura
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  6. Toshio Matsumoto
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Corresponding author

Correspondence to Hiroshi Hagino.

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Hagino, H., Takano, T., Fukunaga, M. et al. Eldecalcitol reduces the risk of severe vertebral fractures and improves the health-related quality of life in patients with osteoporosis. J Bone Miner Metab 31, 183–189 (2013). https://doi.org/10.1007/s00774-012-0397-6

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  • DOI: https://doi.org/10.1007/s00774-012-0397-6

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