UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053591 |
|---|---|
| Receipt number | R000061154 |
| Scientific Title | Development of an Assessment Method for Osteosarcopenia through Simultaneous Measurement of Muscles and Bones |
| Date of disclosure of the study information | 2024/02/11 |
| Last modified on | 2024/02/10 09:32:49 |
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Basic information
Public title
Development of an Assessment Method for Osteosarcopenia through Simultaneous Measurement of Muscles and Bones
Acronym
Development of an Assessment Method for Osteosarcopenia
Scientific Title
Development of an Assessment Method for Osteosarcopenia through Simultaneous Measurement of Muscles and Bones
Scientific Title:Acronym
Development of an Assessment Method for Osteosarcopenia
Region
| Japan |
Condition
Condition
Healthy adults and Patients with Osteoporotic Fractures
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to develop a non-invasive and simultaneous assessment method for measuring bone density (osteoporosis) and skeletal muscle mass (sarcopenia) by applying the first metacarpal bone as a bone indicator.
Basic objectives2
Others
Basic objectives -Others
The assessment of osteosarcopenia poses challenges as it involves invasive measurements of both bone density and skeletal muscle mass. Additionally, the need to evaluate bone density and skeletal muscle mass separately complicates the assessment process, contributing to the limited integration of osteosarcopenia evaluation in routine clinical practice. In this study, we aim to develop a non-invasive and simultaneous assessment method for measuring bone density (osteoporosis) and skeletal muscle mass (sarcopenia) by applying the first metacarpal bone as a bone indicator, which is imaged simultaneously during the measurement of the thumb ball muscle. This innovative approach seeks to address the challenges associated with current osteosarcopenia assessments, potentially facilitating wider adoption in routine clinical evaluations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults and inpatients with osteoporotic fractures
Key exclusion criteria
This study involves the irradiation of the first metacarpal bone, as well as the femoral neck or spine. Individuals deemed inappropriate for radiation exposure by the physician will be excluded. Specifically, pregnant individuals for whom radiation exposure is contraindicated will not be included in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Inoue |
Organization
Niigata University of Health and Welfare
Division name
Department of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-Ku, Niigata City, 950-3198, Japan
TEL
025-250-0829
tatsuro-inoue@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Inoue |
Organization
Niigata University of Health and Welfare
Division name
Department of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-Ku, Niigata City, 950-3198, Japan
TEL
025-250-0829
Homepage URL
tatsuro-inoue@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-Ku, Niigata City, 950-3198, Japan
Tel
025-250-0829
tatsuro-inoue@nuhw.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
| 2024 | Year | 02 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | 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
Osteosarcopenia, the coexistence of osteoporosis and sarcopenia, is a potent risk factor for osteoporotic fractures, a major cause of caregiving dependency. Therefore, the establishment of prevention and treatment strategies through early detection is imperative. In this study, we aim to develop a non-invasive and simultaneous assessment method for measuring bone density (osteoporosis) and skeletal muscle mass (sarcopenia) by applying the first metacarpal bone as a bone indicator.The study initially focuses on validating the accuracy of the first metacarpal bone density by correlating it with the bone density measured using dual-energy X-ray absorptiometry (DXA) in the femoral neck and lumbar spine of healthy adults. Subsequently, we aim to develop a non-invasive method for calculating bone density by converting the first metacarpal bone density into ultrasound spectra.
Management information
Registered date
| 2024 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061154
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