UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035762 |
|---|---|
| Receipt number | R000040735 |
| Scientific Title | Multimodality medical imaging analysis for bone/frailty-brain crosstalk |
| Date of disclosure of the study information | 2019/02/05 |
| Last modified on | 2019/02/03 20:39:11 |
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Basic information
Public title
Multimodality medical imaging analysis for bone/frailty-brain crosstalk
Acronym
Imaging study on bone/frailty-brain crosstalk
Scientific Title
Multimodality medical imaging analysis for bone/frailty-brain crosstalk
Scientific Title:Acronym
Imaging study on bone/frailty-brain crosstalk
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Patients in both men and women aged over 49 years who admitted to our geriatric outpatient service are recruited. They must have a whole-body dual-energy X-ray absorbiometry (DXA) scan.
Basic objectives2
Others
Basic objectives -Others
Patients were assigned into 2 study groups of DXA based bone mineral density (BMD) criteria: with (T-score of <-2.5 SD) or without osteoporosis. As a subgroup, low BMD (T-score of -1 to-2.5 SD). Relationship of BMD in multiple parameters (e.g., cognition, grip, muscle mass, gait parameters, MRI-VBM, SPECT-rCBF) were analyzed between the groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini-mental state examination (MMSE) scores.
Key secondary outcomes
Hand grip, muscle mass, gait parameters (walking speed, cadence, acceleration), blood exam, Areas related to cognitive impairment on brain MRI and SPECT-rCBF. Blood and/or cerebrospinal fluid specimens are stocked for further genomic analysis only after the patients' approval.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who measured Dual-energy X-ray Absorptiometry(DXA) scan.
2) Age over 49 years old in both men and women.
Key exclusion criteria
1) Patients who have already been participated in other research studies.
2) Patients who has a medical history of musculoskeletal, parathyroid, psychological disorders and brain tumors.
3) Contraindication to undergoing MRI scan.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsushi Mutoh |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Nuclear Medicine and Radiology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8559
tmutoh@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Tatewaki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Nuclear Medicine and Radiology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8559
Homepage URL
ysktate@yahoo.co.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None.
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2018-1-618
Org. issuing International ID_1
Tohoku University Graduate School of Medicie
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to clinical data, blood samples are stocked at precision medicine biobank service after patients' approval on a separate informed consent (Registry number: 2018-1-529).
Management information
Registered date
| 2019 | Year | 02 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040735
| 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 |
