UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of correlation among bone density, bone strength and biomarkers in glucocorticoid-induced osteoporosis
Title of the study (Brief title)	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	Hiroko Kanda
Organization	University of Tokyo
Division name	Department of Allergy and Rheumatorogy
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	hkanda-tky@umin.ac.jp

Public contact
Name of contact person	Hiroko Kanda
Organization	University of Tokyo
Division name	Department of Allergy and Rheumatorogy
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	81-03-3815-5411
Homepage URL
Email	hknada-kty@umin.ac.jp

Sponsor
Institute	University of Tokyo, Department of Allergy and Rheumatology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008464