UMIN-CTR Clinical Trial

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	Enrolling by invitation
Date of protocol fixation	2019 Year 11 Month 10 Day
Date of IRB	2020 Year 01 Month 21 Day
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	2029 Year 03 Month 31 Day
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	2021 Year 04 Month 12 Day

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