UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014341 |
|---|---|
| Receipt number | R000016696 |
| Scientific Title | Glucocorticoid-Induced Osteoporosis Treated with Bisphosphonate and Denosumab |
| Date of disclosure of the study information | 2014/06/23 |
| Last modified on | 2019/12/27 11:55:24 |
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Basic information
Public title
Glucocorticoid-Induced Osteoporosis Treated with Bisphosphonate and Denosumab
Acronym
GOBID Study
Scientific Title
Glucocorticoid-Induced Osteoporosis Treated with Bisphosphonate and Denosumab
Scientific Title:Acronym
GOBID Study
Region
| Japan |
Condition
Condition
Glucocorticoid-Induced Osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects of bisphosphonate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in bone mineral density of the lumbar spine
Key secondary outcomes
Safety, Incident vertebral fracture, bone mineral density of the femoral neck, bone makers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Denosumab
Interventions/Control_2
Bisphosphonate
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
Glucocorticoid administered.
Less than 80% (%YAM) of bone mineral density at the lumber spine or femoral neck, or presence of fragile fracture at the spine.
Key exclusion criteria
More than one year of bisphosphontes in 2 years before entry.
Contraindication against bisphosphonates and denosumab.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisaji |
| Middle name | |
| Last name | Oshima |
Organization
Tokyo Medical Center, National Hospital Organization
Division name
Department of Connective Tissue Diseases
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
HOhshima@ntmc-hosp.jp
Public contact
Name of contact person
| 1st name | Hisaji |
| Middle name | |
| Last name | Oshima |
Organization
Tokyo Medical Center, National Hospital Organization
Division name
Department of Connective Tissue Diseases
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
HOhshima@ntmc-hosp.jp
Sponsor or person
Institute
Department of Connective Tissue Diseases, Tokyo Medical Center, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical Center, National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Tokyo Medical Center, National Hospital Organization
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
krinri@ntmc-hosp.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
| 2014 | Year | 06 | Month | 23 | 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
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016696
