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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000019
Receipt No. R000000038
Scientific Title Effect of vitamin D on body sway for old women
Date of disclosure of the study information 2007/04/01
Last modified on 2005/07/05

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Basic information
Public title Effect of vitamin D on body sway for old women
Acronym vitamin D and body sway
Scientific Title Effect of vitamin D on body sway for old women
Scientific Title:Acronym vitamin D and body sway
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluation of vitamin D on body sway for old women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes body sway ,ADL,number of fall
Key secondary outcomes bone mineral density

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 vitaminD and calcium supplement
Interventions/Control_2 bisphosphonate and calcium supplement
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
60 years-old <=
Age-upper limit
90 years-old >=
Gender Female
Key inclusion criteria postmenopausal women who can stand and walk
Key exclusion criteria chronic renal failure patients
patients who already used drug for osteoporosis plan to use
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Koike
Organization osaka city university medical school
Division name Rheumatoid arthritis surgery
Zip code
Address ashahi machi 1-4-3 abeno ward osaka city
TEL 06-6645-3984
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization osaka city university medical school
Division name Rheumatoid arthritis surgery
Zip code
Address ashahi machi 1-4-3 abeno ward osaka city
TEL
Homepage URL
Email

Sponsor
Institute non
Institute
Department

Funding Source
Organization non
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
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
2007 Year 04 Month 01 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
Date of protocol fixation
2005 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 07 Month 05 Day
Last modified on
2005 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000038

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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