UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038532 |
|---|---|
| Receipt number | 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 | 2021/04/12 20:18:26 |
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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
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
horie@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043915
