Comparison of Bone Mineral Loss in 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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303692
• Other study ID #: NIS-OKR-CAS-2010/1
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: January 13, 2015
• Start date: April 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

MC MD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• GnRH Agonist Alone vs. GnRH Agonist Plus Anti-androgen Combination Treated Prostate Cancer Patients
• Prostatic Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of bone density before and after hormone therapy		1 year	No
Primary	comparison of bone density between GnRH agonist alone vs. CAB group		1 year	No
Secondary	correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value		1 year	No
Secondary	correlation between osteoporosis risk factors such as age, weight, history of smoke, history of alcohol and bone density value before and after hormone therapy		1 year	No
Secondary	1year comparison of FRAX score before and after hormonal therapy		1 year	No