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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033899
Receipt No. R000038666
Scientific Title Creation of reference data for bone density
Date of disclosure of the study information 2018/08/27
Last modified on 2018/09/14

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Basic information
Public title Creation of reference data for bone density
Acronym Creation of reference data for bone density
Scientific Title Creation of reference data for bone density
Scientific Title:Acronym Creation of reference data for bone density
Region
Japan

Condition
Condition Bone Fracture, Osteoporosis
Classification by specialty
Orthopedics Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To create reference data for bone density, based on the bone density data collected, using FUJIFILM X-ray imaging equipment.
Basic objectives2 Others
Basic objectives -Others Clarify the difference caused by age and body built.
Trial characteristics_1 Confirmatory
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 Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 x-ray radiography will be performed.
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 1. Subjects who will give written consents for participating in this clinical research
2. Male/Female subjects aged 20 and over
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 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Inoue
Organization SOUSEIKAI PS Clinic
Division name Clinical Research Department
Zip code
Address 6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka,812-0025
TEL 092-283-7777
Email megumi-inoue@lta-med.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Kumashiro
Organization SOUSEIKAI Hakata Clinic
Division name Planning & Coordination Dept.
Zip code
Address 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
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 FUJIFILM Corporation
Name of secondary funder(s) N/A

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人相生会ピーエスクリニック(福岡県)
医療法人相生会墨田病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 27 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 27 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2019 Year 07 Month 31 Day
Date trial data considered complete
2019 Year 07 Month 31 Day
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 26 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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