UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037025
Receipt No. 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 (Ver. 5)

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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
Email 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
Email hiroko-kumashiro@lta-med.com

Sponsor
Institute SOUSEIKAI PS Clinic
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042177