UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026409