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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

February 23, 2011
April 9, 2013
April 2011
January 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01303692 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent

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

MC MD
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent
GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients
Not Provided
  • A
    Total of 250 prostate cancer patients receiving GnRH agonist
  • B
    Total of 250 prostate cancer patients receiving GnRH agonist plus anti-androgen agent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01303692
NIS-OKR-CAS-2010/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Joon Woo Bahn AstraZeneca Korea
AstraZeneca
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP