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Predictors of Hypocalcemia Induced by Denosumab in Patients with Bone Metastases: A Prospective Cohort Study

Research Project

Project/Area Number 17K18114
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Orthopaedic surgery
Research InstitutionShowa University

Principal Investigator

Ishikawa Koji  昭和大学, 医学部, 助教 (40794946)

Project Period (FY) 2017-04-01 – 2020-03-31
Project Status Completed (Fiscal Year 2019)
Budget Amount *help
¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2018: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2017: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Keywordsデノスマブ / 抗RANKLモノクローナル抗体 / 低Ca血症 / 骨転移 / 骨粗鬆症 / 骨代謝回転 / Denosumab / 骨代謝マーカー / 転移性骨腫瘍 / 脊椎転移 / 骨修飾薬 / 予測因子
Outline of Final Research Achievements

Hypocalcemia is the most common major adverse event in patients with bone metastasis receiving denosumab. In the present prospective study, we aimed to identify the risk factors of hypocalcemia. Although all patients received prophylactic administration (ALF: 1.0 ug and Ca: 600mg), 21.4 % and 2.4 % patients developed Grade1 and Grade2 hypocalcemia, respectively. It is possible that severe hypocalcemia was mitigated by oral supplementation. We also revealed that bone turnover markers are potentially useful for prediction of hypocalcemia following denosumab treatment in patients with bone metastasis. Routine measurement of serum calcium concentrations following denosumab is recommended for patients with high bone turnover for timely detection and early treatment initiation.

Academic Significance and Societal Importance of the Research Achievements

担癌患者の骨転移を予防するために抗RANKL抗体は広く臨床で用いられている。
本研究における最大の意義は、骨代謝マーカーを用いることにより、抗RANKL抗体をより安全に投与することができるようになったということである。さらに、厳密に補充療法[活性型VitD製剤(ALF:1.0ug)とCa製剤(600mg)]を設定した研究も過去に少なく、補充療法を決める際の指標になる。投与時に高代謝回転を呈するような患者は十分な補充療法の元、血清Ca値のモニタリングが推奨される。

Report

(4 results)
  • 2019 Annual Research Report   Final Research Report ( PDF )
  • 2018 Research-status Report
  • 2017 Research-status Report
  • Research Products

    (13 results)

All 2020 2019 2018 2017

All Journal Article (11 results) (of which Peer Reviewed: 7 results,  Open Access: 6 results) Presentation (1 results) (of which Int'l Joint Research: 1 results) Book (1 results)

  • [Journal Article] Fracture-Dislocation of the Cervical Spine Secondary to Low-Impact Trauma in a Patient with Klippel-Feil Syndrome: A Case Report2020

    • Author(s)
      Dodo Yusuke、Kudo Yoshifumi、Ishikawa Koji、Yamamura Ryo、Emori Haruka、Maruyama Hiroshi、Matsuoka Akira、Inagaki Katsunori、Toyone Tomoaki
    • Journal Title

      Spine Surgery and Related Research

      Volume: 4 Issue: 1 Pages: 84-86

    • DOI

      10.22603/ssrr.2019-0007

    • NAID

      130007791208

    • ISSN
      2432-261X
    • Year and Date
      2020-01-27
    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Anterior Column Reconstruction Performed for Complete Anterior Longitudinal Ligament Rupture Caused by Surgical Correction with Lateral Interbody Fusion for Kyphosis2020

    • Author(s)
      Yamamura Ryo、Kudo Yoshifumi、Matsuoka Akira、Maruyama Hiroshi、Ishikawa Koji、Dodo Yusuke、Shirahata Toshiyuki、Toyone Tomoaki、Inagaki Katsunori
    • Journal Title

      Spine Surgery and Related Research

      Volume: 4 Issue: 1 Pages: 87-90

    • DOI

      10.22603/ssrr.2018-0097

    • NAID

      130007791213

    • ISSN
      2432-261X
    • Year and Date
      2020-01-27
    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Fracture Management and Current Concepts Related to Pregnancy-Associated Osteoporosis2019

    • Author(s)
      Ishikawa Koji、Nagai Takashi、 Kuroda Takuma, Kudo Yoshifumi, Toyone Tomoaki, Inagaki Katsunori
    • Journal Title

      Clinical Calcium

      Volume: Volume29 Pages: 78-84

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Clinical Features and Diagnosis of Lumbar Fractures Caused by Pregnancy- And Lactation-Associated Osteoporosis2019

    • Author(s)
      Kuroda Takuma、Nagai Takashi、 Ishikawa Koji, Inagaki Katsunori
    • Journal Title

      Clinical Calcium

      Volume: Volume29 Pages: 46-50

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Overview of dropped head syndrome (Combined survey report of three facilities)2019

    • Author(s)
      Endo Kenji、Kudo Yoshifumi、Suzuki Hidekazu、Aihara Takato、Matsuoka Yuji、Murata Kazuma、Takamatsu Taichiro、Sawaji Yasunobu、Nishimura Hirosuke、Matsuoka Akira、Ishikawa Koji、Maruyama Hiroshi、Fukutake Katsunori、Wada Akihito、Takahashi Hiroshi、Toyone Tomoaki、Yamamoto Kengo
    • Journal Title

      Journal of Orthopaedic Science

      Volume: 24 Issue: 6 Pages: 1033-1036

    • DOI

      10.1016/j.jos.2019.07.009

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Analysis of three-dimensional bone mineral density and bone strength measured by quantitative computed tomography following denosumab discontinuation in a patient with postmenopausal osteoporosis</p>2019

    • Author(s)
      Tsuchiya Koki、Ishikawa Koji、Tani Soji、Oshita Yusuke、Kuroda Takuma、Yamamura Ryo、Emori Haruka、Maruyama Hiroshi、Matsuoka Akira、Kudo Yoshifumi、Shirahata Toshiyuki、Toyone Tomoaki、Nagai Takashi、Inagaki Katsunori
    • Journal Title

      Clinical Interventions in Aging

      Volume: Volume 14 Pages: 1445-1450

    • DOI

      10.2147/cia.s205971

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Bone loss caused by dopaminergic degeneration and levodopa treatment in Parkinson’s disease model mice2019

    • Author(s)
      Handa Kazuaki、Kiyohara Shuichi、Yamakawa Tomoyuki、Ishikawa Koji、Hosonuma Masahiro、Sakai Nobuhiro、Karakawa Akiko、Chatani Masahiro、Tsuji Mayumi、Inagaki Katsunori、Kiuchi Yuji、Takami Masamichi、Negishi-Koga Takako
    • Journal Title

      Scientific Reports

      Volume: 9 Issue: 1 Pages: 13768-13768

    • DOI

      10.1038/s41598-019-50336-4

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] デノスマブ初回投与時と2回目投与時の比較における低Ca血症の発症時期とリスク因子の検討―骨代謝回転評価の重要性―2019

    • Author(s)
      土谷 弘樹, 石川 紘司, 永井 隆士, 黒田 拓馬, 伊藤 博, 百々 悠介, 豊根 知明, 稲垣 克記.
    • Journal Title

      The Journal of Japan Osteoporosis Society

      Volume: 5 Pages: 23-30

    • Related Report
      2018 Research-status Report
    • Peer Reviewed
  • [Journal Article] High bone turnover status as a risk factor for symptomatic hypocalcemia following denosumab treatment in patients with osteoporosis. Clin Interv Aging.2018

    • Author(s)
      Koji Ishikawa, Takashi Nagai, Koki Tsuchiya, Yusuke Oshita, Takuma Kuroda, Hiroshi Ito, Soji Tani, Yusuke Dodo, Tomoaki Toyone, Katsunori Inagaki
    • Journal Title

      Clin Interv Aging

      Volume: 8 Pages: 1929-1934

    • Related Report
      2018 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] 骨密度予測因子としての骨代謝マーカーの有用性:多施設共同研究-抗RANKLモノクローナル抗体における、逐次療法の影響-2018

    • Author(s)
      石川 紘司, 永井 隆士, 江黒 剛, 宮城 正行, 井上 玄, 大下 優介, 小口史彦, 阪本 桂造, 高相 昌士, 豊根 知明, 稲垣克記
    • Journal Title

      The Journal of Japan Osteoporosis Society

      Volume: 4 Pages: 399-403

    • Related Report
      2018 Research-status Report
  • [Journal Article] 骨吸収抑制薬と骨質2018

    • Author(s)
      永井 隆士, 石川 紘司, 黒田 拓馬, 大下 優介, 阪本 桂造, 稲垣 克記
    • Journal Title

      Clinical Calcium

      Volume: 27 Pages: 1161-1165

    • Related Report
      2018 Research-status Report
  • [Presentation] An Effect Comparison of Denosumab and SERM on Spinal Instrumentation in Patients with Osteoporosis2019

    • Author(s)
      Ishikawa Koji
    • Organizer
      ISSLS2019
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Book] Bone Joint Nerve2017

    • Author(s)
      石川紘司
    • Total Pages
      6
    • Publisher
      アークメディア
    • Related Report
      2017 Research-status Report

URL: 

Published: 2017-04-28   Modified: 2021-02-19  

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