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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021242
Receipt No. R000024327
Scientific Title Study on the diagnostic method based on the Study of the diagnostic method on the Prediction of bone strength by a quantitative computed tomography-based finite element method
Date of disclosure of the study information 2016/04/01
Last modified on 2018/09/03

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Basic information
Public title Study on the diagnostic method based on the Study of the diagnostic method on the Prediction of bone strength by a quantitative computed tomography-based finite element method
Acronym Study on the diagnosis by the finite element method
Scientific Title Study on the diagnostic method based on the Study of the diagnostic method on the Prediction of bone strength by a quantitative computed tomography-based finite element method
Scientific Title:Acronym Study on the diagnosis by the finite element method
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Endocrinology and Metabolism Geriatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To track the transition of the predicted bone strength value by the bone density values and the CT finite element method by DXA before and after the treatment of osteoporosis intervention, to compare the sensitivity of the therapeutic effect of each diagnostic method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Predicted Bone strength 0,6,12,24months
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 medical treatment with minodronic acid
Period of 24 months
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Osteoporosis was diagnosed based on Diagnostic criteria for primary osteoporosis : year 2012 revision
Key exclusion criteria Exclusion criteria included those who had any recent or current treatment with the potential to alter bone turnover or bone metabolism, patients with dementia, those who could not walk, patients with malignancy, and those who could not take orally bisphosphonate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIROSHI OKAZAKI
Organization Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name Orthopedics
Zip code
Address 1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki City, Kanagawa Prefecture
TEL 044-411-3131
Email okazarov@kantoh.rofuku.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name MASAKO KANEKO
Organization Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name Orthopedics
Zip code
Address 1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki City, Kanagawa Prefecture
TEL 044-411-3131
Homepage URL
Email masako-k@umin.net

Sponsor
Institute Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD
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
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 関東労災病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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 Terminated
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 08 Month 31 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 29 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024327

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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