UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019808 |
|---|---|
| Receipt number | R000022873 |
| Scientific Title | Change of bone quality during endocrine therapy for prostate cancer |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2019/05/20 15:29:41 |
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Basic information
Public title
Change of bone quality during endocrine therapy for prostate cancer
Acronym
Change of bone quality during endocrine therapy for prostate cancer
Scientific Title
Change of bone quality during endocrine therapy for prostate cancer
Scientific Title:Acronym
Change of bone quality during endocrine therapy for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Androgen deprivation therapy is effective treatment for metastatic and advanced prostate cancer. Osteoporosis is one of the most severe adverse events of this treatment. Recently, not only bone mineral density but also bone quality has been reported to be important factor for osteoporosis. However, influence of androgen deprivation therapy on bone quality has not been elucidated. In this study, change of bone quality during endocrine therapy for prostate cancer will be observed.
Basic objectives2
Others
Basic objectives -Others
Primary endpoint: Change of bone quality markers
Secondary endpoint: Change of BMD, incidence of fracture, QOL
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of bone quality markers
Key secondary outcomes
Change of BMD, incidence of fracture, QOL
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Pathologically diagnosed prostate cancer
2) Planned androgen deprivation therapy for more than 1 year as initial therapy.
Key exclusion criteria
1) Prior history of androgen deprivation therapy
2) Prior history of steroidal therapy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Egawa |
Organization
Jikei University School of Medicine
Division name
Department of Urology
Zip code
Address
3-25-8, Nishi shinbashi, Minato-ku, Tokyo
TEL
0334331111
s-egpro@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kimrua |
Organization
Jikei University School of Medicine
Division name
Department of Urology
Zip code
Address
3-25-8, Nishi shinbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
tkimura@jikei.ac.jp
Sponsor or person
Institute
Department of Urology, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 01 | 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
| 2015 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Subjects
Patients with prostate cancer planned of androgen deprivation therapy from Jan 1st, 2016 to Dec 31, 2017.
Observation
1) BMD
2) whole bone scintigram
3) X ray
4) bone quality markers
5) bone metabolic markers
6) QOL
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022873
