UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000016696