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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036851
Receipt No. 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

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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
Email 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
Email reha1@hokuto-kai.com

Sponsor
Institute Social medical corporation Hokutokai Sawa Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041982

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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