UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047918 |
|---|---|
| Receipt number | R000047353 |
| Scientific Title | Evaluation of the relationship among bone strength, alcohol flush syndrome, physical function, motor function, daily function, and quality of life |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/12/01 13:08:24 |
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Basic information
Public title
Evaluation of the relationship among bone strength, alcohol flush syndrome, physical function, motor function, daily function, and quality of life
Acronym
Evaluation of the relationship among bone strength, alcohol flush syndrome, physical function, motor function, daily function, and quality of life
Scientific Title
Evaluation of the relationship among bone strength, alcohol flush syndrome, physical function, motor function, daily function, and quality of life
Scientific Title:Acronym
Evaluation of the relationship among bone strength, alcohol flush syndrome, physical function, motor function, daily function, and quality of life
Region
| Japan |
Condition
Condition
Osteoporisis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship among Alcohol flush syndrome, arteriosclerosis, physical function, motor function, QOL and bone strength analyzed by CT based finite element method. To assess the clinical utility of bone strength measurements compared to bone density measurements. To search for evaluation values that correlate with bone strength before and after exercise intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone Strength
Key secondary outcomes
Bone mineral density
FIM
Blood test (Alb, Ca, P, PINP, Tracp-5b, Whole PTH)
Single standing time
Functional reach test
Time up and go test
10 m walking
QOL(JOQOL)
TMIG Index of competence
index degree of arteriosclerosis
Alcohol flush syndrome
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
General physical therapy, 5 weeks
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria included postmenopausal Japanese aged between 49 and 100 years old.
Key exclusion criteria
Exclusion criteria included patients with prosthetic implants in the proximal femur, those with deformities in the proximal femur associated with fractures or osteoarthritis, those with a history of second lumbar vertebral (L2) fracture, those with prosthetic implants around L2. In addition, subjects were excluded if they had any generalized diseases that affect bone metabolism other than osteoporosis (cancer, rheumatoid arthritis, hyperparathyroidism, Paget's disease, renal dysfunction, Cushing's disease, etc.).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | MASAHIKO |
| Middle name | |
| Last name | BESSHO |
Organization
International University of Health and Welfare (IUHW) Ichikawa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
272-0827
Address
6-1-14 Kounodai Ichikawa-City Chiba prefecture
TEL
047-375-1111
bessho@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | MASAHIKO |
| Middle name | |
| Last name | BESSHO |
Organization
International University of Health and Welfare (IUHW) Ichikawa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
272-0827
Address
6-1-14 Kounodai Ichikawa-City Chiba prefecture
TEL
047-375-1111
Homepage URL
bessho@iuhw.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, International University of Health and Welfare (IUHW) Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare (IUHW) Ichikawa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare (IUHW)
Address
4-1-26 Akasaka Minato-ku Tokyo
Tel
03-5574-3900 (047-375-1111)
rinri_md@iuhw.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
| 2022 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Open public recruiting
Management information
Registered date
| 2022 | Year | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047353
