Unique ID issued by UMIN | UMIN000037240 |
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Receipt number | R000042467 |
Scientific Title | Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients |
Date of disclosure of the study information | 2019/07/07 |
Last modified on | 2019/07/03 00:34:52 |
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in long-term glucocorticoid administration patients
Japan |
glucocorticoid-induced osteoporosis
Clinical immunology |
Others
NO
The objective of this study is to assess the efficacy of romosozumab in glucocorticoid-induced osteoporosis.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The change of bone mineral density at 12 months after initiation of glucocorticoid therapy
The change of bone mineral density at 36 months after initiation of glucocorticoid therapy, the change of bone metabolism markers and adverse events during the observation period
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
4
Treatment
Medicine |
romosozumab group -switch from bisphosphonate-
romosozumab group -switch from denosumab-
bisphosphonate group
denosumab group
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with systemic autoimmune diseases who received bisphosphonate or denosumab for more than half a year and received glucocorticoid therapy with prednisolone at doses over 5 mg daily
2. Patients who agree with this study
1. Patients who have received romosozumab
2. Patients with contraindication for romosozumab or denosumab or bisphosphonate
3. Patients with severe renal dysfunction (eGFR < 30mL/min/1.73m2)
4. Patients who is currently pregnant, breastfeeding or willing to get pregnant
5. Patients who do not give consent to the study
6. Patients who are judged to be inappropriate by the physician
200
1st name | Mai |
Middle name | |
Last name | Kawazoe |
Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine
143-8541
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
03-3762-4151(6595)
mai.kawazoe@med.toho-u.ac.jp
1st name | Mai |
Middle name | |
Last name | Kawazoe |
Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine
143-8541
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
03-3762-4151(6595)
mai.kawazoe@med.toho-u.ac.jp
Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine
Toho University School of Medicine
Division of Rheumatology, Department of Internal Medicine
Self funding
Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
03-3762-4151(6595)
mai.kawazoe@med.toho-u.ac.jp
NO
2019 | Year | 07 | Month | 07 | Day |
Unpublished
Open public recruiting
2019 | Year | 03 | Month | 26 | Day |
2019 | Year | 06 | Month | 27 | Day |
2019 | Year | 07 | Month | 01 | Day |
2022 | Year | 06 | Month | 30 | Day |
2019 | Year | 07 | Month | 03 | Day |
2019 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042467
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