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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014341
Receipt No. 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

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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
Email 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
Email HOhshima@ntmc-hosp.jp

Sponsor
Institute Department of Connective Tissue Diseases, Tokyo Medical Center, National Hospital Organization
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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