UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of EchoS system, ultrasound bone density measuring device, in Japanese women
Acronym	Evaluation of EchoS system in Japanese women
Scientific Title	Evaluation of EchoS system, ultrasound bone density measuring device, in Japanese women
Scientific Title:Acronym	Evaluation of EchoS system in Japanese women
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate and examine the results of EchoS in Japanese women as a conventional bone strength index.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone density using EchoS Bone density using DXA: HSA Bone density / HSA / finite element analysis using CT Perform statistical analysis such as the above correlation.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Bone density measurement using EchoS
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	50 years-old <=
Age-upper limit	100 years-old >=
Gender	Female
Key inclusion criteria	Women performing lower limb artificial joint replacement at our hospital
Key exclusion criteria	Persons with significant deformity of both hip joints or who have implants in the hip joint
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Ohnaru
Organization	Kawasaki medical school
Division name	Department of Orthopedics, Traumatology & Spine Surgery
Zip code	701-0192
Address	577 Matsushima,Kurashiki-City,Okayama Prefecture
TEL	086-462-1111
Email	null.com@mac.com

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Ohnaru
Organization	Kawasaki medical school
Division name	Department of Orthopedics, Traumatology & Spine Surgery
Zip code	701-0192
Address	577 Matsushima,Kurashiki-City,Okayama Prefecture
TEL	086-462-1111
Homepage URL
Email	null.com@mac.com

Sponsor
Institute	Kawasaki medical school
Institute
Department

Funding Source
Organization	Kawasaki medical school
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawasaki medical school
Address	577 Matsushima,Kurashiki-City,Okayama Prefecture
Tel	086-462-1111
Email	kmsrec@med.kawasaki-m.ac.jp

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	2021 Year 06 Month 20 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	Preinitiation
Date of protocol fixation	2021 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 16 Day
Last modified on	2021 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050881