UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036516 |
|---|---|
| Receipt number | R000041602 |
| Scientific Title | Association of osteoporosis with spinal deformity and locomotive syndrome |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2024/04/19 07:20:02 |
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Basic information
Public title
Association of osteoporosis with spinal deformity and locomotive syndrome
Acronym
Association of osteoporosis with spinal deformity and locomotive syndrome
Scientific Title
Association of osteoporosis with spinal deformity and locomotive syndrome
Scientific Title:Acronym
Association of osteoporosis with spinal deformity and locomotive syndrome
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pharmacotherapy is the first choice for treatment of osteoporosis patients. Comprehensive improvement of locomotive Organs involving locomotive syndrome, are important to prevent fractures caused by falls. The purpose of this study is to clarify the relationship between osteoporosis and Locomo and spinal deformity.
Basic objectives2
Others
Basic objectives -Others
Longitudinal study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic information: Age, Sex, Height, Weight, Medical history, Oral medicine
Image analysis: Spine alignment, Local lesion, Bone mineral density
Bone metabolic markers: 25OHD, PTH, ucOC, NTX
Questionnaire: 25-question Geriatric Locomotive Function Scale(GLFS-25), Visual analog scale(VAS)
Motor function: Maximum gait speed, 6-minute walk distance(6MD), Timed up and Go(TUG), One leg standing time, grip strength, Locomotive syndrome risk test( Two step test, Stand up test)
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Osteoporosis
Community dwelling people
Key exclusion criteria
difficulty with independent gait
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Saitama General Hospital
Division name
Saitama Spine Center
Zip code
340-0153
Address
517-5, Yoshino, Satte City, Saitama
TEL
0480-40-1311
yunaka.nakamura@gmail.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Asahi |
Organization
Japan University of Health Sciences
Division name
School of Health Sciences
Zip code
340-0145
Address
2-555, Hirasuka, Satte City, Saitama
TEL
0480-48-6785
Homepage URL
r-asahi@jhsu.ac.jp
Sponsor or person
Institute
Higashi Saitama General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan University of Health Sciences
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
Japan University of Health Sciences
Address
2-555, Hirasuka, Satte City, Saitama
Tel
0480-48-5806
m-sakaue@jhsu.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
| 2019 | Year | 04 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objective of the present study was to investigate the relationship between osteoporosis and Locomo, and spinal deformity. In addition, we will clarify cross-sectional and longitudinal characteristics in osteoporosis patients.
Management information
Registered date
| 2019 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041602
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
