| Project/Area Number |
17K18114
|
|---|
| Research Category |
Grant-in-Aid for Young Scientists (B)
|
| Allocation Type | Multi-year Fund |
|---|
| Research Field |
Medical pharmacy
Orthopaedic surgery
|
|---|
| Research Institution | Showa University |
|---|
Principal Investigator |
|
|---|
| 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。
|
