UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015127 |
|---|---|
| Receipt number | 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 10:04:50 |
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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
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
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
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
takemduro@a6.keio.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017361
