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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007187
Receipt No. 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

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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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008464

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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