UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054876 |
|---|---|
| Receipt number | R000062699 |
| Scientific Title | A prospective longitudinal study of osteoporosis in patients with chronic severe brain injury |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2024/07/04 09:38:15 |
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Basic information
Public title
A prospective longitudinal study of osteoporosis in patients with chronic severe brain injury
Acronym
A prospective longitudinal study of osteoporosis in patients with chronic severe brain injury
Scientific Title
A prospective longitudinal study of osteoporosis in patients with chronic severe brain injury
Scientific Title:Acronym
A prospective longitudinal study of osteoporosis in patients with chronic severe brain injury
Region
| Japan |
Condition
Condition
Chronic severe brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Longitudinal analysis of risk of osteoporosis using Dual-energy X-ray absorptiometry in patients with chronic severe brain injury
Basic objectives2
Others
Basic objectives -Others
Objective assessment of risk of osteoporosis with bone formation and resorption markers in patients with chronic severe brain injury
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
bone mineral density
Key secondary outcomes
bone metabolism marker
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with brain injury admitted to our hospital
2) Patients who can safely undergo radiological examinations
3) Patients who can give consent to participate in the study
Key exclusion criteria
(1) Patients who cannot safely undergo radiological examinations
(2) Patients who cannot give consent for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery
Zip code
261-0012
Address
3-30-1Isobe, Mihama-ku, Chiba-shi, Chiba
TEL
0432770061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery
Zip code
261-0012
Address
3-30-1Isobe, Mihama-ku, Chiba-shi, Chiba
TEL
0432770061
Homepage URL
https://www.chiba-ryougo.jp/
yamakitomohiro@hotmail.com
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Tomohiro Yamaki
Funding Source
Organization
Rehabilitation Center for Traumatic Apallics Chiba
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
Rehabilitation Center for Traumatic Apallics Chiba
Address
Rehabilitation Center for Traumatic Apallics Chiba
Tel
0432770061
y-oomura@chiba-ryougo.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
自動車事故対策機構千葉療護センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 04 | 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
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062699
