UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036851 |
|---|---|
| Receipt number | R000041982 |
| Scientific Title | Effect of comprehensive osteoporosis prevention program on improvement of bone density in elderly persons using psychiatric day care or day/night care |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/05/25 17:21:02 |
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Basic information
Public title
Effect of comprehensive osteoporosis prevention program on improvement of bone density in elderly persons using psychiatric day care or day/night care
Acronym
Effect of comprehensive osteoporosis prevention program on improvement of bone density in elderly persons using psychiatric day care or day/night care
Scientific Title
Effect of comprehensive osteoporosis prevention program on improvement of bone density in elderly persons using psychiatric day care or day/night care
Scientific Title:Acronym
Effect of comprehensive osteoporosis prevention program on improvement of bone density in elderly persons using psychiatric day care or day/night care
Region
| Japan |
Condition
Condition
mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to conduct a study on calcium supplementation and exercise program as an intervention for the prevention or treatment of osteoporosis in elderly psychiatric patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preventive effect of osteoporosis in elderly psychiatric patient
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants undergoing the comprehensive osteoporosis prevention program
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
Male and Female
Key inclusion criteria
Persons taking part in the comprehensive osteoporosis prevention program in a daycare or day / night care
Key exclusion criteria
Persons taking some medicines for osteoporosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsuaki |
| Middle name | |
| Last name | Tanaka |
Organization
Social medical corporation Hokutokai Sawa Hospital
Division name
Day / Night Care
Zip code
561-0803
Address
1-9-1,Shiroyama,Toyonaka,Osaka,Japan
TEL
06-6865-1245
reha1@hokuto-kai.com
Public contact
Name of contact person
| 1st name | Katsuaki |
| Middle name | |
| Last name | Tanaka |
Organization
Social medical corporation Hokutokai Sawa Hospital
Division name
Day / Night Care
Zip code
561-0803
Address
1-9-1,Shiroyama,Toyonaka,Osaka,Japan
TEL
06-6865-1245
Homepage URL
reha1@hokuto-kai.com
Sponsor or person
Institute
Social medical corporation Hokutokai Sawa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee, Social medical corporation Hokutokai
Address
1-9-1,Shiroyama,Toyonaka,Osaka,Japan
Tel
06-6865-1245
reha1@hokuto-kai.com
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
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
37
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
| 2016 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041982
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
