Prostate CancerNCT01025479
Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent
An observational study of Prostate Cancer and Osteoporosis, run by AstraZeneca at 18 sites in South Korea.
Trial summary
Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Osteoporosis
- How many people
- 829 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Nov 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Korean prostate cancer patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting.
Who may be able to join
- pathologic confirmation of prostate cancer
- patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting.
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Research Site
Cheonan-si, Chungcheongnam-do
Research Site
Cheongju-si, North Chungcheong
Research Site
Chungju, North Chungcheong
Research Site
Daegu
Research Site
Daejeon
Research Site
Gangneung-si, Gangwon-do
Research Site
Goyang-si, Gyeonggi-do
Research Site
Gumi, Gyeongsangbuk-do
Research Site
Guri-si, Gyeonggi-do
Research Site
Gwangju
Research Site
Gyeongju, Gyeongsangbuk-do
Research Site
Iksan-si, Jeollabuk-do
Research Site
Incheon
Research Site
Jeju City
Research Site
Masan-si, Gyeongsangnam-do
Research Site
Pusan
Research Site
Seoul
Research Site
Ulsan
About this study
Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen
- Conditions
- Prostate Cancer, Osteoporosis
- Keywords
- Osteoporosis, Prostate cancer, LHRH agonist and/or anti-androgen agent, Korean prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joon Woo Bahn, MD, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025479
- Sponsor's protocol ID
- NIS-OKR-CAS-2009/1
- Status last verified
- Jun 2010
- First submitted
- 1 Dec 2009
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent
- ClinicalTrials.gov ID
- NCT01025479
- Acronym / sponsor ID
- NIS-OKR-CAS-2009/1
- Conditions
- Prostate Cancer, Osteoporosis
- Keywords
- Osteoporosis, Prostate cancer, LHRH agonist and/or anti-androgen agent, Korean prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevalence rate of osteoporosis and it's actual management condition in Prostate cancer patients who takes LHRH antagonist and anti androgen
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Korean prostate cancer patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting.
Key inclusion criteria (2 listed)
- pathologic confirmation of prostate cancer
- patients who are taking LHRH antagonist or anti- androgen or both of them within 6 months since starting.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon Woo Bahn, MD study director
AstraZeneca Korea
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Osteoporosis, run by AstraZeneca at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010.