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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name