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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01303692
First received: February 23, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • comparison of bone density before and after hormone therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • comparison of bone density between GnRH agonist alone vs. CAB group [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 1year comparison of FRAX score before and after hormonal therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 327
Study Start Date: April 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Total of 250 prostate cancer patients receiving GnRH agonist
B
Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent

Detailed Description:

MC MD

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303692

Locations
Korea, Republic of
Research Site
Seongnam-si, Gyeonggi-do, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon Woo Bahn AstraZeneca Korea
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01303692     History of Changes
Other Study ID Numbers: NIS-OKR-CAS-2010/1
Study First Received: February 23, 2011
Last Updated: May 13, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
bone mineral loss
prostate cancer
GnRH agonist alone vs. GnRH agonist plus anti-androgen combination

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Androgens
Deslorelin
Enzyme Inhibitors
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014