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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015126
Receipt No. R000017362
Scientific Title A clinical study to evaluate the efficacy of bone-modyfying agent for the patients of prostate cancer.
Date of disclosure of the study information 2014/09/12
Last modified on 2018/10/10

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Basic information
Public title A clinical study to evaluate the efficacy of bone-modyfying agent for the patients of prostate cancer.
Acronym A clinical study to evaluate the efficacy of BMA for the patients of PCa.
Scientific Title A clinical study to evaluate the efficacy of bone-modyfying agent for the patients of prostate cancer.
Scientific Title:Acronym A clinical study to evaluate the efficacy of BMA for the patients of PCa.
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficasy of BMA for patients of PCa
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SRE
QOL
Key secondary outcomes bone fracture
pain

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male
Key inclusion criteria patients of prostate cancer
Key exclusion criteria patients who don't want to participate in this study
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mototsugu Oya
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email moto-oya@z3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Kosaka
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email takemduro@a6.keio.jp

Sponsor
Institute Department of Urology, Keio University School of Medicine
Institute
Department

Funding Source
Organization self funding
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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 12 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 Completed
Date of protocol fixation
2014 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We get information from medical records.

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017362

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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