UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007187 |
|---|---|
| Receipt number | R000008464 |
| Scientific Title | Assessment of correlation among bone density, bone strength and biomarkers in glucocorticoid-induced osteoporosis |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2019/01/19 17:28:13 |
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Basic information
Public title
Assessment of correlation among bone density, bone strength and biomarkers in glucocorticoid-induced osteoporosis
Acronym
Bone density, bone strength and biomarkers in GIO
Scientific Title
Assessment of correlation among bone density, bone strength and biomarkers in glucocorticoid-induced osteoporosis
Scientific Title:Acronym
Bone density, bone strength and biomarkers in GIO
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of correlation among bone density, bone strength and biomarkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation and change of bone density, bone strength and biomarkers
Key secondary outcomes
relationship between fracture and bone density, bone strength and biomarkers
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
treatment of more than PSL 5mg/day for 2 years
Key exclusion criteria
1, started of medication for osteoporosis
2, diabetes
3, hypertyroidism
4, hyperparatyroidism
5, liver cirrhosis
6, renal dysfunction
7, inflammatory bowel disease
8, warfarization
9, pregnancy, lactation
10, fracture in the past
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Kanda |
Organization
University of Tokyo
Division name
Department of Allergy and Rheumatorogy
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
hkanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Kanda |
Organization
University of Tokyo
Division name
Department of Allergy and Rheumatorogy
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-03-3815-5411
Homepage URL
hknada-kty@umin.ac.jp
Sponsor or person
Institute
University of Tokyo,
Department of Allergy and Rheumatology
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo,
Department of Allergy and Rheumatology
Organization
Division
Category of Funding Organization
Other
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
東京大学医学部付属病院
アレルギー・リウマチ内科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 01 | 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
| 2010 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
measurement of bone density, bone strength and biomarkers in 4, 12 and 24 months after steroid treatment
Management information
Registered date
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008464
| 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 |
