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Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis

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Abstract

Summary

The efficacy of once-weekly risedronate with and without cholecalciferol in bone mineral density (BMD) in Korean patients with osteoporosis was compared. After 12 months, both spine and hip BMD increased significantly in both groups, but there was no significant difference between two groups.

Introduction

This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis.

Methods

This was a prospective, 12-month, randomized, open-labeled, actively controlled trial involving 41 hospitals. A total of 841 subjects with osteoporosis were randomized to once-weekly risedronate (35 mg) and cholecalciferol (5600 IU) in a single pill (RSD+, n = 642) or once-weekly risedronate (35 mg) alone (RSD, n = 199). BMD was measured via dual-energy X-ray absorptiometry at the lumbar spine and hip, and the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assayed at baseline and after 12 months of treatment.

Results

After 12 months, the lumbar spine, femoral neck, and total hip BMD increased significantly in both groups; there was no significant difference between two groups. Women in the RSD+ group exhibited significantly increased lumbar spine BMD, and subjects with previous fracture history in the RSD+ group had significantly increased total hip BMD compared with the RSD group. The serum 25(OH) D level increased significantly in the RSD+ group. The serum PTH level decreased in the RSD+ group but increased in the RSD group. The serum ALP level significantly decreased in both groups; there was no significant difference between two groups.

Conclusions

A once-weekly pill containing risedronate and cholecalciferol had the equivalent antiresorptive efficacy on BMD compared with risedronate alone and improved 25(OH) D serum levels after 12 months of treatment without significant adverse events in Korean patients with osteoporosis.

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Funding

This study was supported by Hanlim Pharmaceutical Co., Seoul, South Korea.

Author information

Authors and Affiliations

  1. Department of Endocrinology and Metabolism, Kyung Hee University Hospital, Seoul, Republic of Korea

    So Young Park

  2. Department of Endocrinology and Metabolism, The Catholic University of Korea, Seoul ST. Mary’s Hospital, Seoul, Republic of Korea

    Moo-Il Kang

  3. Department of Obstetrics and Gynecology, Chung-Ang University Hospital, Seoul, Republic of Korea

    Hyung Moo Park

  4. Severance Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

    Yumie Rhee

  5. Department of Orthopaedic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea

    Seong Hwan Moon

  6. Department of Endocrinology and Metabolism, Dankook University, Cheil General Hospital, Seoul, Republic of Korea

    Hyun Koo Yoon

  7. Department of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Jung-Min Koh

  8. Department of Orthopaedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Jae Suk Chang

  9. Department of Endocrinology and Metabolism, Pusan National University Hospital, Busan, Republic of Korea

    In Joo Kim

  10. Department of Orthopaedic Surgery, Ajou University Medical Center, Suwon, Republic of Korea

    Ye Yeon Won

  11. Department of Orthopaedic Surgery, Hanyang University Guri Hospital, Seoul, Republic of Korea

    Ye Soo Park

  12. Department of Obstetrics and Gynecology, Inje University Sanggye Paik Hospital, Seoul, Republic of Korea

    Hoon Choi

  13. Department of Endocrinology and Metabolism, Seoul National University College of Medicine, Seoul, Republic of Korea

    Chan Soo Shin

  14. Department of Orthopaedic Surgery, Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea

    Taek Rim Yoon

  15. Department of Clinical Epidemiology and Biostatistics, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea

    Sung-Cheol Yun

  16. Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University, School of Medicine, 892 Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea

    Ho-Yeon Chung

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  1. So Young Park
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  2. Moo-Il Kang
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  7. Jung-Min Koh
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  15. Sung-Cheol Yun
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the IDEAL Trial Investigators

Corresponding author

Correspondence to Ho-Yeon Chung.

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The institutional review boards of all involved centers approved the study, and informed consent was obtained from all participants.

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None.

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A complete list of the investigators in the IDEAL trial is provided in the Supplementary Appendix.

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Park, S.Y., Kang, MI., Park, H.M. et al. Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis. Arch Osteoporos 15, 3 (2020). https://doi.org/10.1007/s11657-019-0663-5

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