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Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01025479
First received: December 1, 2009
Last updated: June 28, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition
Prostate Cancer
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prevalence of Osteoporosis in Korean Prostate Cancer Patients Who is Receiving LHRH Agonist and/or Anti-androgen Agent

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 829
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025479

Locations
Korea, Republic of
Research Site
Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Research Site
Chungju-si, Chungcheongbuk-do, Korea, Republic of
Research Site
Cheonan-si, Chungcheongnam-do, Korea, Republic of
Research Site
Gangneung-si, Gangwon-do, Korea, Republic of
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of
Research Site
Guri-si, Gyeonggi-do, Korea, Republic of
Research Site
Gumi-si, Gyeongsangbuk-do, Korea, Republic of
Research Site
Gyeongju-si, Gyeongsangbuk-do, Korea, Republic of
Research Site
Masan-si, Gyeongsangnam-do, Korea, Republic of
Research Site
Iksan-si, Jeollabuk-do, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Daejeon, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Incheon, Korea, Republic of
Research Site
Jeju, Korea, Republic of
Research Site
Pusan, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Ulsan, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon Woo Bahn, MD AstraZeneca Korea
  More Information

No publications provided

Responsible Party: AstraZeneca, AstraZeneca MCMD
ClinicalTrials.gov Identifier: NCT01025479     History of Changes
Other Study ID Numbers: NIS-OKR-CAS-2009/1
Study First Received: December 1, 2009
Last Updated: June 28, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Osteoporosis
Prostate cancer
LHRH agonist and/or anti-androgen agent
Korean prostate cancer

Additional relevant MeSH terms:
Osteoporosis
Prostatic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Androgens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones

ClinicalTrials.gov processed this record on May 19, 2013