UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010025 |
|---|---|
| Receipt number | 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 12:04:37 |
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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
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
yaota@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011608
