UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014972 |
|---|---|
| Receipt number | R000017425 |
| Scientific Title | Temporal change of MRI findings in osteoporotic vertebral fracture: A multicenter prospective study |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2016/08/27 20:21:06 |
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Basic information
Public title
Temporal change of MRI findings in osteoporotic vertebral fracture: A multicenter prospective study
Acronym
Temporal MRI findings in OVF
Scientific Title
Temporal change of MRI findings in osteoporotic vertebral fracture: A multicenter prospective study
Scientific Title:Acronym
Temporal MRI findings in OVF
Region
| Japan |
Condition
Condition
Osteoporotic vertebral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the natural course of MRI findings in osteoporotic vertebral fracture
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peudarthrosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Osteoporotic Vertebral Fracture
Key exclusion criteria
Dementia, Infection, Cancer
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nakamura |
Organization
Osaka city university
Division name
Orthopaedic surgery
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka city, Osaka, Japan
TEL
06-6645-3851
shinji@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Takahashi |
Organization
Osaka city university
Division name
Orthopaedic surgery
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka city, Osaka, Japan
TEL
06-6645-3851
Homepage URL
shinji@med.osaka-cu.ac.jp
Sponsor or person
Institute
Investigator initiated study
Institute
Department
Personal name
Funding Source
Organization
Japan Orthopaedic and Traumatology Foundation, Inc.
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 30 | Day |
Other
Other related information
Case series
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2016 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017425
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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