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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032869
Receipt No. R000037476
Scientific Title The Japanese Population-Based Osteoporosis (JPOS) Cohort Study
Date of disclosure of the study information 2018/07/01
Last modified on 2019/06/19

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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
Email 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
Email hyg_ph@osaka-med.ac.jp

Sponsor
Institute A society for the study of Calcium intake and Osteoporosis
Institute
Department

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
Email 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
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2024 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
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037476

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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