Unique ID issued by UMIN | UMIN000037579 |
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Receipt number | R000042716 |
Scientific Title | Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis |
Date of disclosure of the study information | 2019/08/02 |
Last modified on | 2022/08/05 14:21:59 |
Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis
Evaluation of efficacy and safety of romosozumab for osteoporosis in HD patients
Evaluation of efficacy and safety of anti-sclerostin antibody romosozumab for osteoporosis in patients undergoing hemodialysis
Evaluation of efficacy and safety of romosozumab for osteoporosis in HD patients
Japan |
osteoporosis, end stage renal disease
Nephrology | Orthopedics |
Others
NO
To assess percent change from baseline in bone mineral density after 1-year romosozumab treatment
Safety,Efficacy
Percent change from baseline in bone mineral density at month 12
Monthly serum calcium and phosphate levels
Serum intact PTH, FGF23, BAP and TRACP5b levels at month 1, month 3, month 6, month 9 and month 12
Percent change of aortic calcification score from baseline
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) patient undergoing hemodialysis for more than 3 months
2) patient with osteoporosis who is scheduled to receive monthly subcutaneous romosozumab therapy
3) patient who is competent to understand the aim of this study and agree on it
None
25
1st name | Hirotaka |
Middle name | |
Last name | Komaba |
Tokai University School of Medicine
Division of Nephrology, Endocrinology and Metabolism
2591193
143, Shimokasuya, Isehara, Kanagawa, Japan
0463-93-1121
hkomaba@tokai-u.jp
1st name | Naoto |
Middle name | |
Last name | Hamano |
Tokai University School of Medicine
Division of Nephrology, Endocrinology and Metabolism
2591193
143, Shimokasuya, Isehara, Kanagawa, Japan
0463-93-1121
nhamano@tokai.ac.jp
Tokai University School of Medicine
The Kidney Foundation, Japan
Other
Japan
Medical Corporation Showakai
Institutional Review Board for Clinical Research, Tokai University
143, Shimokasuya, Isehara, Kanagawa, Japan
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
NO
東海大学医学部附属病院(神奈川県),望星平塚クリニック(神奈川県),東海大学医学部付属大磯病院(神奈川県)
2019 | Year | 08 | Month | 02 | Day |
Unpublished
Completed
2019 | Year | 07 | Month | 09 | Day |
2019 | Year | 07 | Month | 23 | Day |
2019 | Year | 08 | Month | 02 | Day |
2021 | Year | 03 | Month | 31 | Day |
We compare percent changes of BMD in patients in this study with those of propensity score-matched patients involved in the cohort study we previously performed.
2019 | Year | 08 | Month | 02 | Day |
2022 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042716
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