UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005433 |
|---|---|
| Receipt number | R000006442 |
| Scientific Title | A multicenter,openlabel,randomized controlled traial for the head-to-head comparison of minodronic acid hydroate and raloxifene hydrocloride |
| Date of disclosure of the study information | 2011/04/13 |
| Last modified on | 2023/11/13 10:59:49 |
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Basic information
Public title
A multicenter,openlabel,randomized controlled traial for the head-to-head comparison of minodronic acid hydroate and raloxifene hydrocloride
Acronym
A-TOP/JOINT-04
Scientific Title
A multicenter,openlabel,randomized controlled traial for the head-to-head comparison of minodronic acid hydroate and raloxifene hydrocloride
Scientific Title:Acronym
A-TOP/JOINT-04
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Obstetrics and Gynecology |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The head-to-head comparison of minodronic acid hydorate and raloxifene hydroclodide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Osteoporotic fractures,Vertebral fractures,Major osteoporotic fractures
Key secondary outcomes
Bone density,HSA,height,Bone-related markers,lipid,Oral interview surveys,the number of falls,falls score,care level,morter function,QOL,Safty
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
minodronic acid hydroate
Interventions/Control_2
raloxifene hydorocloride
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
| Not applicable |
Gender
Female
Key inclusion criteria
Women over 60,one or more risk of A-TOP risk factors for fractur ken
Key exclusion criteria
Using therapeutic drug contraindications,Secondary osteoporousis and Disease with low bone mass,
Advanced variant T4-L4,
Heart disease,liver disease,kidney failure or other serious complications
Problems with the reliability of interview data
Treatment of malignant tumors that may affect bone metabolism
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Orimo |
Organization
Japan Osteoporosis Foundation
Division name
president
Zip code
1030024
Address
11-2Nihombashi kobune-cho,Chuo-ku,Tokyo,Japan
TEL
03-5640-1841
hajime-orimo@kenkoin.jp
Public contact
Name of contact person
| 1st name | Yoji |
| Middle name | |
| Last name | Mitadera |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Adequate Treatment of Osteoporosis
Zip code
1690051
Address
1-1-7Nishiwaseda,Shinjuku-ku,Tokyo, Japan
TEL
03-5287-2638
Homepage URL
http://www.a-top.jp
a-top@csp.or.jp
Sponsor or person
Institute
Research committee of A-TOP
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2011 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
http://www.a-top.jp
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006442
| Research Plan | |
|---|---|
| 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 |
