UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042107 |
|---|---|
| Receipt number | R000048053 |
| Scientific Title | Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2021/10/15 10:31:56 |
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Basic information
Public title
Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis
Acronym
Evaluation of the Therapeutic Effect of Denosumab on Rheumatoid Arthritis and Osteoporosis
Scientific Title
Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis
Scientific Title:Acronym
Evaluation of the Therapeutic Effect of Denosumab on Rheumatoid Arthritis and Osteoporosis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of denosumab in treating osteoporosis and inhibiting bone erosion in rheumatoid arthritis cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Bone Mineral Density at week 52
Key secondary outcomes
Evaluation of Bone Erosion at week 52
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Meet the diagnosis of rheumatoid arthritis and osteoporosis
Key exclusion criteria
Use of parathyroid hormones drugs
History of bone metabolic disease
hypocalcemia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Orthopedic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177245
yu-mori@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Orthopedic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177245
Homepage URL
yu-mori@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2020 | Year | 10 | Month | 14 | 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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048053
