UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042021 |
|---|---|
| Receipt number | R000047958 |
| Scientific Title | Effects of sarcopenia on osteoporosis |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2020/10/06 00:22:54 |
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Basic information
Public title
Effects of sarcopenia on osteoporosis
Acronym
Effects of sarcopenia on osteoporosis
Scientific Title
Effects of sarcopenia on osteoporosis
Scientific Title:Acronym
Effects of sarcopenia on osteoporosis
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of sarcopenia on quality of life in patients with osteoporosis
Basic objectives2
Others
Basic objectives -Others
Relationship between spinal alignment and skeletal muscle mass
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with osteoporosis
Key exclusion criteria
patients with difficulty walking or standing, or pacemaker
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ryuki |
| Middle name | Hashida |
| Last name | Hashida |
Organization
Kurume University
Division name
Division of Orthopedics
Zip code
8300011
Address
Asahi-machi 67, Kurume-shi, Fukuoka
TEL
0942317568
hashida_ryuuki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | RYUKI |
| Middle name | |
| Last name | Hashida |
Organization
Kurume University
Division name
Division of Orthopedics
Zip code
8300011
Address
Asahi-machi 67, Kurume-shi, Fukuoka
TEL
0942317568
Homepage URL
hashida_ryuuki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Japan Orthopaedics and Traumatology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Hospital
Address
Asahi-machi 67, Kurume-shi, Fukuoka
Tel
0942-65-3749
i_rinri@kurume-u.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
| 2020 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
a
Publication of results
Unpublished
Result
URL related to results and publications
a
Number of participants that the trial has enrolled
100
Results
The prevalence of sarcopenia in this group of osteoporosis patients was 32%. Sarcopenia was significantly associated with QOL and spinal alignment.
Results date posted
| 2020 | Year | 10 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Osteoporosis
Participant flow
Osteoporosis
Adverse events
None
Outcome measures
JOABPEQ
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047958
