UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052096 |
|---|---|
| Receipt number | R000059458 |
| Scientific Title | Therapeutic effects of brace for acute osteoporotic vertebral fracture |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/09/03 10:20:55 |
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Basic information
Public title
Therapeutic effects of brace for acute osteoporotic vertebral fracture
Acronym
Therapeutic effects of brace for acute osteoporotic vertebral fracture
Scientific Title
Therapeutic effects of brace for acute osteoporotic vertebral fracture
Scientific Title:Acronym
Therapeutic effects of brace for acute osteoporotic vertebral fracture
Region
| Japan |
Condition
Condition
Osteoporotic Vertebral Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence and necessity of external fixation devices on osteoporotic vertebral fractures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in activities of daily living
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older with fresh osteoporotic vertebral fracture who were able to start treatment within 2 weeks of injury
Key exclusion criteria
Patients with a main fracture secondary to another vertebral body within 6 months after the main fracture
Patients with major fractures who are eligible for surgery at the start of treatment
Patients who did not consent to the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Funayama |
Organization
Institute of Medicine, 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
Institute of Medicine, 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
JA Kyosairen
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 and 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
| 2023 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2023 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | 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=R000059458
