Unique ID issued by UMIN | UMIN000036837 |
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Receipt number | R000041967 |
Scientific Title | Examination of efficacy and safety treated by romosozumab or denosumab in osteoporosis with collagen disease including glucocorticoid-induced osteoporosis |
Date of disclosure of the study information | 2019/05/25 |
Last modified on | 2019/05/24 06:03:45 |
Examination of efficacy and safety treated by romosozumab or denosumab in osteoporosis with collagen disease including glucocorticoid-induced osteoporosis
Efficacy and safety treated by romosozumab or denosumab in osteoporosis with collagen disease including GIO
Examination of efficacy and safety treated by romosozumab or denosumab in osteoporosis with collagen disease including glucocorticoid-induced osteoporosis
Efficacy and safety treated by romosozumab or denosumab in osteoporosis with collagen disease including GIO
Japan |
osteoporosis with collagen disease including glucocorticoid-induced osteoporosis
Clinical immunology | Orthopedics |
Others
NO
The aim of this study is to examine the efficacy and safety treated by romosozumab or denosumab for 1 year in osteoporosis with collagen disease including glucocorticoid-induced osteoporosis
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Bone mineral density at 12 months after treatment
Occurrence of hypocalcemia
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
No need to know
2
Treatment
Medicine |
romosozumab plus active vitamin D group
denosumab plus active vitamin D group
20 | years-old | <= |
Not applicable |
Female
1:Osteoporosis patients with collagen disease over 20 years old
2:GIO patients over 20 years old
3:Patients who agree with this study
1:Patients who have taken romosozumab or denosumab before
2:Patients who are allergic to romosozumab or denosumab or eldecalcitol
3:Hypocalcemia
4:Pregnant or breast-feeding patients
5:Patients with severe renal function (eGFR 30 ml / min / 1.73 m2) or patients undergoing dialysis
6:Patients at risk of hypercalcemia (patients with renal dysfunction, patients with malignancy, patients with primary hyperparathyroidism)
7:Patients with severe liver dysfunction
8:Patients with urolithiasis and patients with a history of their history
9:Others, patients judged by the research director as inappropriate
60
1st name | Yukio |
Middle name | |
Last name | Nakamura |
Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
390-8621
Asahi 3-1-1, Matsumoto 3908621, Japan
0263372659
yxn14@aol.jp
1st name | Yukio |
Middle name | |
Last name | Nakamura |
Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
390-8621
Asahi 3-1-1, Matsumoto 3908621, Japan
0263372659
yxn14@aol.jp
Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
Self funding
Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Asahi 3-1-1, Matsumoto 3908621, Japan
0263372659
yxn14@aol.jp
NO
2019 | Year | 05 | Month | 25 | Day |
Partially published
Open public recruiting
2019 | Year | 05 | Month | 13 | Day |
2019 | Year | 05 | Month | 24 | Day |
2019 | Year | 05 | Month | 24 | Day |
2024 | Year | 05 | Month | 13 | Day |
2019 | Year | 05 | Month | 24 | Day |
2019 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041967
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