UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033899
Receipt number R000038666
Scientific Title Creation of reference data for bone density
Date of disclosure of the study information 2018/08/27
Last modified on 2019/09/13 10:14:38

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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 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

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

Completed

Date of protocol fixation

2018 Year 08 Month 09 Day

Date of IRB

2018 Year 08 Month 24 Day

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

2019 Year 09 Month 13 Day



Link to view the page

Value
https://center6.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