UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023212 |
|---|---|
| Receipt number | R000026409 |
| Scientific Title | Analysis of bone microstructure of the radial distal site in anorexia nervosa |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2021/01/20 12:41:50 |
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Basic information
Public title
Analysis of bone microstructure of the radial distal site in anorexia nervosa
Acronym
Analysis of bone microstructure of the radial distal site in anorexia nervosa
Scientific Title
Analysis of bone microstructure of the radial distal site in anorexia nervosa
Scientific Title:Acronym
Analysis of bone microstructure of the radial distal site in anorexia nervosa
Region
| Japan |
Condition
Condition
anorexia nervosa
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study , we analyze bone microstructure of anorexia nervosa patients using high resolution CT (HR-pQCT), and compare with healthy subjects , we reveal the specific bone microstructure of anorexia nervosa patients.
The data obtained in this study , not only reveal the causes of bone fragility , the reasons of high fracture rates of anorexia nervosa patients and the future therapies .
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cortical bone microstructure
Key secondary outcomes
Cancellous bone microstructure , bone density , prediction of bone strength , blood test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5 females of anorexia nervosa
After checked the examination, when judged necessity of treatment, done the medicine.
Interventions/Control_2
Data of 10 people is picked out from analysis of osteoporosis by HR-pQCT (N=500)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
I.Age: At the time of obtaining informed consent , age 20 years of age or older
II.gender: female
III.Patients with a treatment history of anorexia nervosa
IV.After having received a sufficient explanation upon participation in this study , on a thorough understanding , patient with consent of the free will .
Key exclusion criteria
I.A person who has an autoimmune disease ( such as rheumatoid arthritis)
II.Pregnant women, women who has the possibility of pregnancy
III.Others , patients investigator deems unsuitable as research subjects
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Matsubayashi |
Organization
Graduate school of biomedical sciences Nagasaki university
Division name
Department of orthopedic surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
+81958197321
bayazarov@gmail.com
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Matsubayashi |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of orthopedic surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
+81958197321
Homepage URL
bayazarov@gmail.com
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto
Tel
+81958197321
bayazarov@gmail.com
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
| 2016 | Year | 12 | Month | 31 | 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
The bone microstructure of anorexianervosa patiens resembled postmenopausal womens'.
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
| 2016 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
anorexia nervosa pateints
Management information
Registered date
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026409
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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