Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent

NCT ID: NCT01303692

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-02-28

Brief Summary

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Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent

Detailed Description

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MC MD

Conditions

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GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Total of 250 prostate cancer patients receiving GnRH agonist

No interventions assigned to this group

B

Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joon Woo Bahn

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28262724 (View on PubMed)

Other Identifiers

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NIS-OKR-CAS-2010/1

Identifier Type: -

Identifier Source: org_study_id

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