Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
January 13, 2015 updated by: AstraZeneca
Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
Study Overview
Status
Completed
Detailed Description
MC MD
Study Type
Observational
Enrollment (Actual)
312
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of
- Research Site
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
Description
Inclusion Criteria:
- Korean prostate cancer over 50 years old with pathological confirmation
- Patients receiving GnRH antagonist or GnRH agonist plus anti- androgen combination within 6 months since starting.
- Patients measured bone density level before starting to receive hormone therapies above.
Exclusion Criteria:
- Patients who are treated other anti-osteoporosis drugs and who are treated bisphosphate due to BMD T score below -3.0.
- Patients who are hard to be analysed by attach to other bone disease.
- Patients who are hard to be analysed by limitation of chart record according to investigators'discretion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
A
Total of 250 prostate cancer patients receiving GnRH agonist
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|
B
Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
comparison of bone density before and after hormone therapy
Time Frame: 1 year
|
1 year
|
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comparison of bone density between GnRH agonist alone vs. CAB group
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value
Time Frame: 1 year
|
1 year
|
|
correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value before and after hormone therapy
Time Frame: 1 year
|
1 year
|
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1year comparison of FRAX score before and after hormonal therapy
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
February 23, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (ESTIMATE)
February 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-OKR-CAS-2010/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.