Unique ID issued by UMIN | UMIN000039889 |
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Receipt number | R000045493 |
Scientific Title | Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis |
Date of disclosure of the study information | 2020/03/31 |
Last modified on | 2021/09/20 21:49:09 |
Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Evaluation of the efficacy of romosozumab for hemodialysis patients with hemodialysis
Japan |
osteoporosis
Endocrinology and Metabolism | Nephrology | Orthopedics |
Others
NO
The subject is a dialysis patient with osteoporosis.
Observe patients receiving romosozumab for one year and evaluate bone density, vascular calcification, and bone metabolic markers before and after administration.
Safety,Efficacy
Bone mineral density at 12 months after treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Injections of romosozumab (at a dose of 210 mg) monthly for 12 months
20 | years-old | <= |
Not applicable |
Male and Female
Patients 20 years or older with chronic hemodialysis patients with osteoporosis who have not sufficiently improved osteoporosis even after standard treatment for 6 months or more.
1)Patients who are not receiving standard treatment for osteoporosis
2)Persons who are contraindicated in taking evenity or denosumab
3)Patients who have taken romosozumab or denosumab within 6 months
4)Hypocalcemia
5)Patients with severe liver dysfunction, heart dyfunction, malignant tumor
6)Patients who are judged by the investigator not to be eligible for drug administration.
20
1st name | Tomohiro |
Middle name | |
Last name | Saito |
Showa University School of Medicine
Department of Medicine, Division of Nephrology
142-8555
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
0337848000
saitou1986@med.showa-u.ac.jp
1st name | Tomohiro |
Middle name | |
Last name | Saito |
Showa University School of Medicine
Department of Medicine, Division of Nephrology
142-8555
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
0337848000
saitou1986@med.showa-u.ac.jp
Showa University
Self funding
Self funding
Japan
Ethics comittiee of Showa university
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
03-3784-8000
m-rinri@ofc.showa-u.ac.jp
NO
2020 | Year | 03 | Month | 31 | Day |
Unpublished
18
Completed
2020 | Year | 03 | Month | 20 | Day |
2019 | Year | 07 | Month | 11 | Day |
2020 | Year | 03 | Month | 20 | Day |
2022 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 20 | Day |
2021 | Year | 09 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045493
Research Plan | |
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Registered date | File name |
2021/09/20 | ②研究実施計画書 20190807最終版.pdf |
Research case data specifications | |
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Registered date | File name |
2021/09/20 | dataset.pdf |
Research case data | |
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Registered date | File name |
2021/09/20 | data.pdf |