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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:
ClinicalTrials.gov Identifier:
NCT01303692
First Posted: February 25, 2011
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 ]
  • comparison of bone density between GnRH agonist alone vs. CAB group [ Time Frame: 1 year ]

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 ]
  • 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 ]
  • 1year comparison of FRAX score before and after hormonal therapy [ Time Frame: 1 year ]

Enrollment: 312
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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01303692     History of Changes
Other Study ID Numbers: NIS-OKR-CAS-2010/1
First Submitted: February 23, 2011
First Posted: February 25, 2011
Last Update Posted: January 14, 2015
Last Verified: January 2015

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
Androgens
Deslorelin
Triptorelin Pamoate
Androgen Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists