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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005433
Receipt No. 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 2018/10/12

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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 Obsterics 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
Middle name
Last name Hajime Orimo
Organization Japan Osteoporosis Foundation
Division name president
Zip code
Address 11-2Nihombashi kobune-cho,Chuo-ku,Tokyo,103-0024 Japan
TEL 03-5640-1841
Email hajime-orimo@kenkoin.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayumi Tsukiyama
Organization Public Health Research Foundation
Division name Comprehensive Support Project for Adequate Treatment of Osteoporosis
Zip code
Address 1-1-7Nishiwaseda,Shinjuku-ku,Tokyo,169-0051 japan
TEL 03-5287-2633
Homepage URL http://www.a-top.jp
Email tsukiyama@csp.or.jp

Sponsor
Institute Research committee of A-TOP
Institute
Department

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
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
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
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
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006442

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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