UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022967 |
|---|---|
| Receipt number | R000026474 |
| Scientific Title | Analysis of bone fracture healing by using high-resolution peripheral quantitative CT (HR-pQCT) |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/07/27 13:31:02 |
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Basic information
Public title
Analysis of bone fracture healing by using high-resolution peripheral quantitative CT (HR-pQCT)
Acronym
Analysis of bone fracture healing by using HR-pQCT
Scientific Title
Analysis of bone fracture healing by using high-resolution peripheral quantitative CT (HR-pQCT)
Scientific Title:Acronym
Analysis of bone fracture healing by using HR-pQCT
Region
| Japan |
Condition
Condition
Distal radius fracture or scaphoid fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the mechanism of fracture healing in the longitudinal analysis of hand and forearm fractures by using HR-pQCT
Basic objectives2
Others
Basic objectives -Others
Analysis of the change of bone microstructure and bone strength in the process of bone healing
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density of the fracture region at 1, 4, 8, 12, 16, 20, and 24 weeks after injury
Key secondary outcomes
Trabecular bone microstructure, cortical bone microstructure, and estimated bone strength at 1, 4, 8, 12, 16, 20, and 24 weeks after injury
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
1) The patients with distal radius fracture or scaphoid fracture
2) A written informed consent for the participation in the study
Key exclusion criteria
1) The patients with the past history of the same part fracture
2) Patients with metabolic diseases which may affect to the bone metabolism (e.g.,rheumatoid arthritis)
3) Patients treated with medication which affect to the bone metabolism (e.g., glucocorticosteroids)
4) Patients judged to be inadequate for this study by investigators
Target sample size
55
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
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of orthopaedic surgery, Nagaski University Hospital
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
16031418
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
| 2016 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
The patients with distal radius fracture or scaphoid fracture who consult Nagasaki university hospital after Mach 2016 and who is eligible for the inclusion criteria
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026474
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
