UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003967 |
|---|---|
| Receipt number | R000004782 |
| Scientific Title | Pathophysiological study on periarticular osteoporosis in Rheumatoid Arthritis |
| Date of disclosure of the study information | 2010/07/30 |
| Last modified on | 2018/02/06 23:12:32 |
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Basic information
Public title
Pathophysiological study on periarticular osteoporosis in Rheumatoid Arthritis
Acronym
Periarticular osteoporosis in RA
Scientific Title
Pathophysiological study on periarticular osteoporosis in Rheumatoid Arthritis
Scientific Title:Acronym
Periarticular osteoporosis in RA
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the pathophysiology of periarticular osteoporosis in RA, bone and cellular samples are to be retrieved and examined histologically and biologically.
Basic objectives2
Others
Basic objectives -Others
The correlation between disease activity and osteoporosis is to be analyzed.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
bone formation and bone resorption functions of bone marrow cells
Key secondary outcomes
bone mineral density and micro-architecture
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo total joint arthroplasty and give a full consent to this study, and patients with RA or primary osteoporosis giving a full consent to this study
Key exclusion criteria
Patients who cannot give a full consent to this study including children and cognitively-ill patients
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakamura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
075-751-3652
hiromu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL
075-751-3652
Homepage URL
http://www.kuhp.kyoto-u.ac.jp/~seikeigeka/
hiromu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Kyoto University Graduate 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
Address
Tel
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
medication, treatment history, laboratory data, urinary data, BMD, MRI, CT, X-ray, DAS28(ESR)
Management information
Registered date
| 2010 | Year | 07 | Month | 29 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004782
| 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 |
