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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01025479
Other study ID # NIS-OKR-CAS-2009/1
Secondary ID
Status Completed
Phase N/A
First received December 1, 2009
Last updated June 28, 2010
Start date November 2009
Est. completion date March 2010

Study information

Verified date June 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen


Recruitment information / eligibility

Status Completed
Enrollment 829
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- pathologic confirmation of prostate cancer

- patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting.

Exclusion Criteria:

- patients who are hard to be analysed by limitation of chart record according to investigators'discretion

- patients who already have been registered in this study

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Research Site Cheonan-si Chungcheongnam-do
Korea, Republic of Research Site Cheongju-si Chungcheongbuk-do
Korea, Republic of Research Site Chungju-si Chungcheongbuk-do
Korea, Republic of Research Site Daegu
Korea, Republic of Research Site Daejeon
Korea, Republic of Research Site Gangneung-si Gangwon-do
Korea, Republic of Research Site Goyang-si Gyeonggi-do
Korea, Republic of Research Site Gumi-si Gyeongsangbuk-do
Korea, Republic of Research Site Guri-si Gyeonggi-do
Korea, Republic of Research Site Gwangju
Korea, Republic of Research Site Gyeongju-si Gyeongsangbuk-do
Korea, Republic of Research Site Iksan-si Jeollabuk-do
Korea, Republic of Research Site Incheon
Korea, Republic of Research Site Jeju
Korea, Republic of Research Site Masan-si Gyeongsangnam-do
Korea, Republic of Research Site Pusan
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Ulsan

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary To define prevalence rate of osteoporosis in Prostate cancer patients who take LHRH antagonist or anti androgen (include MAB) at the stage of before treatment or it's initial stage.
Secondary To assess whether proper osteoporosis prevention and treatment was given or not according to osteoporosis treatment guideline in prostate cancer patients who are enrolled in this study.
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