UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028825 |
|---|---|
| Receipt number | 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 18:19:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ishikawa@hc-sys.jp
Sponsor or person
Institute
Chie Miyazaki ladies clinic
Institute
Department
Personal name
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
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
Value
https://center6.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 |
