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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035762
Receipt No. R000040735
Official scientific title of the study 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

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Basic information
Official scientific title of the study Multimodality medical imaging analysis for bone/frailty-brain crosstalk
Title of the study (Brief title) 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 Tatsushi Mutoh
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Nuclear Medicine and Radiology
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-8559
Email tmutoh@tohoku.ac.jp

Public contact
Name of contact person Yasuko Tatewaki
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Nuclear Medicine and Radiology
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-8559
Homepage URL
Email ysktate@yahoo.co.jp

Sponsor
Institute Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 11 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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