UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021242 |
|---|---|
| Receipt number | 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 10:23:59 |
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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
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
masako-k@umin.net
Sponsor or person
Institute
Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
