UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017945 |
|---|---|
| Receipt number | R000020800 |
| Scientific Title | Effects of drugs on the treatment of osteoporosis in rheumatoid arthritis patinets |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2020/12/21 07:05:56 |
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Basic information
Public title
Effects of drugs on the treatment of osteoporosis in rheumatoid arthritis patinets
Acronym
Effects of drugs on the treatment of osteoporosis in rheumatoid arthritis patinets
Scientific Title
Effects of drugs on the treatment of osteoporosis in rheumatoid arthritis patinets
Scientific Title:Acronym
Effects of drugs on the treatment of osteoporosis in rheumatoid arthritis patinets
Region
| Japan |
Condition
Condition
osteoporosis in rheumatoid arthtitis patients
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate quantitatively the effects of drugs in Rheumatoid Arthritis paitents using several methods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone mineral density
bone strength assessed by finite element analysis
bone turnover marker
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
osteoporosis in rheumatoid arthritis
Key exclusion criteria
malignancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | sakae |
| Middle name | |
| Last name | Tanaka |
Organization
The university of Tokyo hospital
Division name
department of orthopaedic surgery
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-3815-5411
tanakas-ort@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Ono |
Organization
The university of Tokyo hospital
Division name
department of orthopaedic surgery
Zip code
113-0033
Address
ongo 7-3-1, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
kumi_on206@yahoo.co.jp
Sponsor or person
Institute
The university of Tokyo hospital
Institute
Department
Personal name
Funding Source
Organization
The university of Tokyo hospital
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
The university of Tokyo Hospital
Address
7-3-1, Hongo, Bunkyoku, Tokyo, 113-0033, Japan
Tel
03-3815-5411
onok-ort@ims.u-tokyo.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
| 2015 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
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
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The analysis has been performed.
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020800
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
