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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028825
Receipt No. R000032992
Scientific Title Survey on fracture rate of the elderly by measuring spot urine equol
Date of disclosure of the study information 2017/08/25
Last modified on 2019/04/04

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Basic information
Public title Survey on fracture rate of the elderly by measuring spot urine equol
Acronym Survey on fracture rate of the elderly by measuring spot urine equol
Scientific Title Survey on fracture rate of the elderly by measuring spot urine equol
Scientific Title:Acronym Survey on fracture rate of the elderly by measuring spot urine equol
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the correlation between equol producing status and fracture rate.
Basic objectives2 Others
Basic objectives -Others Correlation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Equol, questionnaire
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Persons who himself or the prospective legally acceptable representative received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Women living in long-term care health facilities
Key exclusion criteria 1.Persons who are judged inappropriate for the exam by the principal investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chie Miyazaki
Organization Chie Miyazaki ladies clinic
Division name Hospital director
Zip code
Address 1972-5 Nagara, Gifu-shi, Gifu, JAPAN
TEL 058-233-5553
Email chiechan@city.gifu.med.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 0368092722
Homepage URL
Email ishikawa@hc-sys.jp

Sponsor
Institute Chie Miyazaki ladies clinic
Institute
Department

Funding Source
Organization Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 25 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 Completed
Date of protocol fixation
2017 Year 08 Month 09 Day
Date of IRB
2017 Year 08 Month 09 Day
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
2018 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observation study, investigate the correlation between fracture history and current equol production status. The recruitment period is from August 2017 to December 2017, those who live in the aged care nursing homes visited by the principal investigators, and who meet the inclusion criteria and do not meet the exclusion criteria will be included.

Management information
Registered date
2017 Year 08 Month 25 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032992

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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