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Recruitment status Terminated
Unique ID issued by UMIN UMIN000015127
Receipt No. R000017361
Scientific Title A clinical study to evaluate the preventive effect of denosumab(Pralia) on bone loss in men receiving androgen-deprivation therapy for prostate cancer.
Date of disclosure of the study information 2014/09/12
Last modified on 2017/06/29

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Basic information
Public title A clinical study to evaluate the preventive effect of denosumab(Pralia) on bone loss in men receiving androgen-deprivation therapy for prostate cancer.
Acronym A clinical study to evaluate the preventive effect of Pralia on bone loss in men receiving ADT for PCa.
Scientific Title A clinical study to evaluate the preventive effect of denosumab(Pralia) on bone loss in men receiving androgen-deprivation therapy for prostate cancer.
Scientific Title:Acronym A clinical study to evaluate the preventive effect of Pralia on bone loss in men receiving ADT for PCa.
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the preventive effect of denosumab(Pralia) on bone loss in men receiving androgen-deprivation therapy for prostate cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SRE
QOL
Key secondary outcomes bone density
marker of bone metabolism
pain

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 pralia
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male
Key inclusion criteria For prostate cancer patients who recieve ADT
Key exclusion criteria patients who have dental caries and osteonecrosis of the jaw
Target sample size 40

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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 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 Terminated
Date of protocol fixation
2014 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2017 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017361


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