UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032139 |
|---|---|
| Receipt number | R000036666 |
| Scientific Title | Bone microstructure after surgical treatment for Graves' disease, estimated by high-resolution peripheral quantitative computed tomography (HR-pQCT). |
| Date of disclosure of the study information | 2018/04/18 |
| Last modified on | 2020/10/09 12:48:19 |
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Basic information
Public title
Bone microstructure after surgical treatment for Graves' disease, estimated by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Acronym
Bone microstructure after surgical treatment for Graves' disease, estimated by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Scientific Title
Bone microstructure after surgical treatment for Graves' disease, estimated by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Scientific Title:Acronym
Bone microstructure after surgical treatment for Graves' disease, estimated by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Region
| Japan |
Condition
Condition
Grave's disease
Classification by specialty
| Endocrine surgery | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate changes in bone mineral density, markers of bone metabolism, and bone microstructure estimated by HR-pQCT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone microstructure by HR-pQCT, at preoperation and 6 and 12 months after thyroid surgery,
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients that will undergo thyroid surgery for Grave's disease.
Key exclusion criteria
Patients that have systemic bone disease already (i. e. arthrorheumatism)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
TEL
+81-(0)95-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosho Yamanouchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
TEL
+81-(0)95-819-7316
Homepage URL
koshoy@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate School of Biomedical Sciences
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
Address
Tel
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
| 2018 | Year | 04 | Month | 18 | 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
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
evaluation at preparation and 6 and 12 months after thyroid surgery.
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036666
