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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010025
Receipt No. R000011608
Scientific Title Histomorphometric and micro CT analyses in patients with adolescent idiopathic scoliosis
Date of disclosure of the study information 2013/02/14
Last modified on 2017/08/18

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Basic information
Public title Histomorphometric and micro CT analyses in patients with adolescent idiopathic scoliosis
Acronym Histomorphometric and micro CT study in patients with adolescent idiopathic scoliosis
Scientific Title Histomorphometric and micro CT analyses in patients with adolescent idiopathic scoliosis
Scientific Title:Acronym Histomorphometric and micro CT study in patients with adolescent idiopathic scoliosis
Region
Japan

Condition
Condition adolescent idiopathic scoliosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To characterize bone metabolism in adolescent idiopathic scoliosis patients.
Basic objectives2 Others
Basic objectives -Others This histomorphometric study is to characterize bone metabolism in AIS patients by using bone metabolism markers; BAP (bone formation marker) and TRAP5b (bone resorption marker).
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes histomorphometric analysis
Key secondary outcomes bone metabolism markers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Presurgical use of tetracycline
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
10 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria Candidates for idiopathic scoliosis surgery
Key exclusion criteria syndromic, congenital, and degenerative scoliosis
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Aota
Organization Yokohama City University
Division name Dept. of Orthhopaedics
Zip code
Address 3-9 Fukuura, Kanazawa-ku,Yokohama City
TEL 045-787-2655
Email yaota@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Aota
Organization Yokohama City University
Division name Dept. of Orthhopaedics
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL (045)787-2654
Homepage URL
Email yaota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Japan Osteoporosis Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 横浜市立脳血管医療センター(神奈川県)、神奈川県立こども医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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 02 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 15 Day
Last follow-up date
2015 Year 08 Month 13 Day
Date of closure to data entry
2016 Year 08 Month 11 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 13 Day
Last modified on
2017 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011608

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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