UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030289 |
|---|---|
| Receipt number | R000034588 |
| Scientific Title | The impact of masticatory ability on bone mineral density in young women |
| Date of disclosure of the study information | 2017/12/06 |
| Last modified on | 2020/12/08 15:11:04 |
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Basic information
Public title
The impact of masticatory ability on bone mineral density in young women
Acronym
The impact of masticatory ability on bone mineral density in young women
Scientific Title
The impact of masticatory ability on bone mineral density in young women
Scientific Title:Acronym
The impact of masticatory ability on bone mineral density in young women
Region
| Japan |
Condition
Condition
osteopenia/osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of masticatory ability on bone mineral density in healthy young women
Basic objectives2
Others
Basic objectives -Others
To examine the effect of masticatory ability on bone mineral density independent of nutrition or exercise habit in healthy young women
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bone mineral density
Key secondary outcomes
masticatory ability, the intake of protein, vitamin D, and calcium, exercise habit
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy women
Key exclusion criteria
1.existence of oral disease
2.history of the fracture of calcaneus
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
+81-6-6605-2947
yokoyama@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
+81-6-6605-2947
Homepage URL
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
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
Osaka City University, medical research ethics committee
Address
1-2-7-601, Asahi-Machi, Abeno-ku, Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.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
| 2017 | Year | 12 | Month | 06 | 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
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Masticatory ability, the intake of protein, vitamin D, and calcium, exercise habit, and bone mineral density will be evaluated in all participants, and the relationship between bone mineral density and all the other factors will be cross-sectionally assessed. The impact of masticatory ability on bone mineral density independent of nutrition, or exercise habit will be also analyzed.
Management information
Registered date
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034588
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/06/08 | 3907実施計画書.docm |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/06/08 | 3907審査申請書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/06/08 | 被験者データ（匿名化）190308.xlsx |
