UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037239 |
|---|---|
| Receipt number | R000042464 |
| Scientific Title | Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in initial glucocorticoid administration patients |
| Date of disclosure of the study information | 2019/07/07 |
| Last modified on | 2019/07/03 00:30:17 |
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Basic information
Public title
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in initial glucocorticoid administration patients
Acronym
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in initial glucocorticoid administration patients
Scientific Title
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in initial glucocorticoid administration patients
Scientific Title:Acronym
Evaluation of the efficacy of romosozumab for glucocorticoid-induced osteoporosis in initial glucocorticoid administration patients
Region
| Japan |
Condition
Condition
glucocorticoid-induced osteoporosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the efficacy of romosozumab in glucocorticoid-induced osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of bone mineral density at 12 months after initiation of glucocorticoid therapy
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
romosozumab group
Interventions/Control_2
denosumab group
Interventions/Control_3
bisphosphonate group
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with systemic autoimmune diseases who commenced glucocorticoid therapy with prednisolone at doses over 15 mg daily
2. Patients who agree with this study
Key exclusion criteria
1. Patients who have received romosozumab or denosumab or bisphosphonate
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
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Mai |
| Middle name | |
| Last name | Kawazoe |
Organization
Toho University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151(6595)
mai.kawazoe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Kawazoe |
Organization
Toho University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151(6595)
Homepage URL
mai.kawazoe@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo, Japan
Tel
03-3762-4151(6595)
mai.kawazoe@med.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042464
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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