UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032869 |
|---|---|
| Receipt number | R000037476 |
| Scientific Title | The Japanese Population-Based Osteoporosis (JPOS) Cohort Study |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2024/07/09 15:01:46 |
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Basic information
Public title
The Japanese Population-Based Osteoporosis (JPOS) Cohort Study
Acronym
The Japanese Population-Based Osteoporosis (JPOS) Cohort Study
Scientific Title
The Japanese Population-Based Osteoporosis (JPOS) Cohort Study
Scientific Title:Acronym
The Japanese Population-Based Osteoporosis (JPOS) Cohort Study
Region
| Japan |
Condition
Condition
Osteoporotic fracture
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the estimated prevalence rate and health burden of osteoporosis
Basic objectives2
Others
Basic objectives -Others
To ascertain the incidence of osteoporotic fractures and investigate the health checkup items for osteoporosis screening to prevent osteoporotic fracture
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Osteoporotic fracture
Key secondary outcomes
Osteoporosis
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
We randomly selected community-dwelling women from each of the 5-year age groups raging from 15 to 79 year according to resident registrations at seven municipalities at the baseline survey in 1996.
Key exclusion criteria
Not applicable
Target sample size
4550
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | IKI |
Organization
Kindai University Faculty of Medicine
Division name
Department of Public Health
Zip code
589-8511
Address
377-2 Oono-higashi, Osaka-Sayama, Osaka 589-8511
TEL
072-366-0021
pbl-h@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | TAMAKI |
Organization
Osaka Medical College
Division name
Department of Hygiene & Public Health
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki City Osaka, 569-8686
TEL
072-863-1221
Homepage URL
hyg_ph@osaka-med.ac.jp
Sponsor or person
Institute
A society for the study of Calcium intake and Osteoporosis
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science, Livestock Industry Promotion Cooperation (Current, Agriculture and Livestock Industries Corporation)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine IRB
Address
377-2,Ono-higashi,Osakasayama,Osaka,Japan
Tel
072-366-0221
zizen@med.kindai.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
大阪医科大学 / Osaka Medical College
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.med.kindai.ac.jp/pubheal/jpos/index.html
Publication of results
Partially published
Result
URL related to results and publications
http://www.med.kindai.ac.jp/pubheal/jpos/index.html
Number of participants that the trial has enrolled
3984
Results
The age-specific reference values of bone mineral density (BMD), bone turnover markers, hip structural analysis, and trabecular bone score, which is a surrogate measure of bone microarchitecture, in Japanese women have been presented using baseline data. Additionally, the cut-off value of BMD for osteoporosis screening has been indicated.
Results date posted
| 2019 | Year | 06 | Month | 19 | Day |
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
No longer recruiting
Date of protocol fixation
| 1996 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 1996 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
The risk of non-vertebral fractures in subjects with 25(OH)D levels of <10 ng/mL was 6.55 times higher than that in subjects with 25(OH)D levels of >=30 ng/mL over a period of 5 years. Additionally, 25(OH)D levels of <20 ng/mL were significantly associated with an increased risk of non-vertebral fractures over a period of 15 years.
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037476
