GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer PatientsNCT01303692
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
An observational study of GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients, run by AstraZeneca at 2 sites in South Korea.
Trial summary
Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients
- How many people
- 312 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2011to Feb 2014
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
About this study
Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
Read the detailed description
MC MD
- Conditions
- GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients
- Keywords
- bone mineral loss, prostate cancer, GnRH agonist alone vs. GnRH agonist plus anti-androgen combination
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Total of 250 prostate cancer patients receiving GnRH agonist | |
| B | Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of bone density before and after hormone therapy
Measured: 1 year
comparison of bone density between GnRH agonist alone vs. CAB group
Measured: 1 year
Secondary outcomes (3)
correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value
Measured: 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
Measured: 1 year
1year comparison of FRAX score before and after hormonal therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer PatientsStudies 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
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joon Woo Bahn, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303692
- Sponsor's protocol ID
- NIS-OKR-CAS-2010/1
- Status last verified
- Jan 2015
- First submitted
- 23 Feb 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SH, Joung JY, Kim S, Rha KH, Kim HG, Kwak C, Lee JY, Jeon SS, Hong SK, Jeong H, Jo MK, You D, Jeong IG, Hong JH, Kim CS. Comparison of bone mineral loss by combined androgen block agonist versus GnRH in patients with prostate cancer: A 12 month-prospective observational study. Sci Rep. 2017 Mar 6;7:39562. doi: 10.1038/srep39562.
PubMed 28262724
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
- ClinicalTrials.gov ID
- NCT01303692
- Acronym / sponsor ID
- NIS-OKR-CAS-2010/1
- Conditions
- GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients
- Keywords
- bone mineral loss, prostate cancer, GnRH agonist alone vs. GnRH agonist plus anti-androgen combination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Feb 2011 (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.
Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
Detailed description
MC MD
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Total of 250 prostate cancer patients receiving GnRH agonist |
| B | – | –Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
comparison of bone density before and after hormone therapy
Time frame: 1 year
comparison of bone density between GnRH agonist alone vs. CAB group
Time frame: 1 year
3 secondary outcomes
correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value
Time frame: 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
1year comparison of FRAX score before and after hormonal therapy
Time frame: 1 year
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 14 Jan 2015.
- Derived from this study: PubMed 28262724Kim SH, Joung JY, Kim S, Rha KH, Kim HG, Kwak C, Lee JY, Jeon SS, Hong SK, Jeong H, Jo MK, You D, Jeong IG, Hong JH, Kim CS. Comparison of bone mineral loss by combined androgen block agonist versus GnRH in patients with prostate cancer: A 12 month-prospective observational study. Sci Rep. 2017 Mar 6;7:39562. doi: 10.1038/srep39562.
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 study director
AstraZeneca Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients, run by AstraZeneca at 2 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 3 inclusion and 3 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 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
comparison of bone density before and after hormone therapy (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303692, which also lists 1 linked publication.
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 14 Jan 2015.