UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000019 |
|---|---|
| Receipt number | 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 14:38:42 |
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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
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
Sponsor or person
Institute
non
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
