UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037025 |
|---|---|
| Receipt number | R000042177 |
| Scientific Title | Evaluation of the reproducibility, and the effects of different imaging conditions on bone density measurement acquired by X-ray apparatus |
| Date of disclosure of the study information | 2019/06/11 |
| Last modified on | 2020/05/25 14:14:57 |
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Basic information
Public title
Evaluation of the reproducibility, and the effects of different imaging conditions on bone density measurement acquired by X-ray apparatus
Acronym
Evaluation of the reproducibility, and the effects of different imaging conditions on bone density measurement acquired by X-ray apparatus
Scientific Title
Evaluation of the reproducibility, and the effects of different imaging conditions on bone density measurement acquired by X-ray apparatus
Scientific Title:Acronym
Evaluation of the reproducibility, and the effects of different imaging conditions on bone density measurement acquired by X-ray apparatus
Region
| Japan |
Condition
Condition
Bone Fracture, Osteoporosis
Classification by specialty
| Orthopedics | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bone density will be measured using X-ray imaging equipment. The reproducibility of the results will be evaluated by imaging the same subjects more than once. The influence of conditions on bone density measurement will also be evaluated by differently setting up of the x-ray equipment. The correlation with bone density results acquired by other manufacturer's imaging equipment will also be evaluated.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the reproducibility, and the effects of different imaging conditions on bone density measurement acquired by X-ray apparatus
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Check X-ray images
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
X-ray radiography of lumbar spine will be performed.
Interventions/Control_2
X-ray radiography of femur will be performed.
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Subjects who will give written consents for participating in this clinical research
2. Female subjects aged between 30 and 69 (inclusive).
Key exclusion criteria
1. Subjects who are either pregnant or breast-feeding.
2. Subjects who are clearly suffering from serious acute disease.
3. Subjects who have history of previous or current fracture of femur and/or lumbar.
4. Subjects who have been diagnosed with osteoporosis.
5. Subjects who are considered inappropriate as research subjects by PIs.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Haranaka |
| Middle name | |
| Last name | Miwa |
Organization
SOUSEIKAI PS Clinic
Division name
Clinical Research Dept.
Zip code
812-0025
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
TEL
092-283-7777
miwa-haranaka@lta-med.com
Public contact
Name of contact person
| 1st name | Kumashiro |
| Middle name | |
| Last name | Hiroko |
Organization
SOUSEIKAI
Division name
Department of Strategy & Business Development
Zip code
812-0025
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
TEL
0922837701
Homepage URL
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI PS Clinic
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.com
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 | 06 | Month | 11 | 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
400
Results
Bone density was measured using X-ray imaging equipment. The reproducibility of the results was evaluated by imaging the same subjects more than once. The influence of conditions on bone density measurement was also evaluated by differently setting up of the x-ray equipment. The correlation with bone density results acquired by other manufacturer's imaging equipment was also evaluated.
Results date posted
| 2020 | Year | 05 | Month | 24 | Day |
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
| 2019 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 11 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042177
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
