UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045644 |
|---|---|
| Receipt number | R000052107 |
| Scientific Title | The optimal treatment for fresh osteoporotic vertebral fracture with poor prognostic MRI findings |
| Date of disclosure of the study information | 2021/10/10 |
| Last modified on | 2022/10/03 12:39:29 |
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Basic information
Public title
The optimal treatment for fresh osteoporotic vertebral fracture with poor prognostic MRI findings
Acronym
The optimal treatment for fresh OVF with poor prognostic MRI findings
Scientific Title
The optimal treatment for fresh osteoporotic vertebral fracture with poor prognostic MRI findings
Scientific Title:Acronym
The optimal treatment for fresh OVF with poor prognostic MRI findings
Region
| Japan |
Condition
Condition
osteoporotic vertebral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether a conservative treatment with initial bed rest prevents from vertebral collapse progression and decrease surgical cases in fresh OVF
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of conservative treatment failure within 6 months.
Key secondary outcomes
Fusion rate, progression of vertebral collapse, progression of local kyphosis, decrease in activity of daily living
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
| 60 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who begins to receive conservative treatment within 2 weeks after injury.
Key exclusion criteria
Secondary osteoporosis patients, high energy injury
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Funayama |
Organization
University of Tsukuba
Division name
Orthopaedic Surgery
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3219
funatoru3@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Funayama |
Organization
University of Tsukuba
Division name
Orthopaedic Surgery
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3219
Homepage URL
funatoru3@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Osteoporosis Society
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
Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.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 | 10 | Month | 10 | 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
82
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 | 10 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The rate of conservative treatment failure, fusion rate, progression of vertebral collapse, progression of local kyphosis and decrease of activity of daily living will be investigated.
Management information
Registered date
| 2021 | Year | 10 | Month | 02 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052107
