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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01303692
First received: February 23, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 500
Study Start Date: April 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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
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: April 9, 2013
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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Androgens
 Deslorelin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013