UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019960 |
|---|---|
| Receipt number | R000021320 |
| Scientific Title | Reserch about precision of HR-pQCT |
| Date of disclosure of the study information | 2015/11/27 |
| Last modified on | 2020/08/03 12:22:47 |
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Basic information
Public title
Reserch about precision of HR-pQCT
Acronym
Reserch about precision of HR-pQCT
Scientific Title
Reserch about precision of HR-pQCT
Scientific Title:Acronym
Reserch about precision of HR-pQCT
Region
| Japan |
Condition
Condition
not designated
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the precision of measurement of high-resolution peripheral quantitative CT (HR-pQCT)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraobserver reproducibility of trabecular and cortical microstructure, and finite-element analysis
Key secondary outcomes
Interobserver reproducibility of trabecular and cortical microstructure, and finite-element analysis
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age:over 20 when we get consent
Sex:no object
In or out patient: no object
Patients after receiving a sufficient explanation Upon participation in this study, on the thorough understanding, that document consent is obtained by the free will of the study in person
Key exclusion criteria
Those with missing limbs
Those who can not be limbs of rest and retention
Patients that may have been pregnant and pregnant
Others, who principal investigator has determined to be inappropriate as a subject
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL
095-819-7321
kohchiba@estate.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL
095-819-7321
Homepage URL
kohchiba@estate.ocn.ne.jp
Sponsor or person
Institute
Nagaski University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagaski University Hospital Department of orthopaedic surgery
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 Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
27-5-16
Org. issuing International ID_1
Clinical reserch, Nagasaki University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長崎大学病院（長崎県）/ Nagasaki University Hospital (Nagasaki prefecture)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: A cohort study
Patients recruitment: All that meet the selection criteria in patients admitted to our facility or volunteers from August 2015 to September 2015.
Data collection: Trabecular and cortical bone microstructure parameters and micro-finite-element analysis
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021320
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
