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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038532
Receipt No. R000043915
Scientific Title Analysis of bone microstructure using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with Cushing syndrome
Date of disclosure of the study information 2019/11/10
Last modified on 2019/11/10

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Basic information
Public title Analysis of bone microstructure using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with Cushing syndrome
Acronym Analysis of bone microstrucure using HR-pQCT in Cushing syndrome
Scientific Title Analysis of bone microstructure using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with Cushing syndrome
Scientific Title:Acronym Analysis of bone microstrucure using HR-pQCT in Cushing syndrome
Region
Japan

Condition
Condition Cushing syndrome
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyse bone mictrostructural change using second generation HR-pQCT in Japanese patients with Cushing syndrome.
Basic objectives2 Others
Basic objectives -Others Observational study of bone microstructure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone microstructure compared to those of healthy control.
Key secondary outcomes Changes in bone microstructure in patients with Cushing syndrome from baseline to 1 or 2 years after adrenalectomy.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Cushing syndrome based on the criteria of Japan Endocrine socitety
Key exclusion criteria 1. Patients who was administered within 3 months with teriparatide, denosumab and romosozumab.
2. Patinets administered with steroids.
3. Patients compricated with malignancy.
4. Pregnant or brest feeding.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Horie
Middle name
Last name Ichiro
Organization Nagasaki University Hospital
Division name Department of Endocrinology and Metabolism
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197200
Email horie@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Horie
Middle name
Last name Ichiro
Organization Nagasaki University Hospital
Division name Department of Endocrinology and Metabolism
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197200
Homepage URL
Email horie@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Endocrinology and Metabolism
Address 1-7-1 Sakamoto, Nagasaki
Tel 0958197200
Email horie@nagasaki-u.ac.jp

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
2019 Year 11 Month 10 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
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
2019 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No other information

Management information
Registered date
2019 Year 11 Month 10 Day
Last modified on
2019 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043915

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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