UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023212
Receipt No. 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 2019/07/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email bayazarov@gmail.com

Sponsor
Institute Nagasaki university
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 18 Day
Date of IRB
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
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.