Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

Prostate Cancer Clinical Trial

— Osteoporosis  

Official title:

Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00957606
• Other study ID #: PCa & Osteoporosis 09
• Secondary ID: S-20080004
• Status: Recruiting
• Phase: Phase 3
• First received: August 11, 2009
• Last updated: April 12, 2011
• Start date: August 2009
• Est. completion date: September 2013

Study information

• Verified date: April 2011
• Source: Odense University Hospital
• Contact: Mads H Poulsen, MD
• Email: Mads.Poulsen[@]ouh.regionsyddanmark.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is

• to determine the rate of osteoporosis among patients with advanced prostate cancer.

• to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.

Description:

Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy.

The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Prostate cancer

• Initiation of androgen deprivation therapy

• Oral and written informed consent

Exclusion Criteria:

• They withdraw their consent

• Treatment for osteoporosis within the last year

• Other malignancy

• Other bone disease, bedbound, use of steroid

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Androgen Deprivation Therapy
• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• blood sampling, DXA-scan, bone scintigraphy
Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times

Locations

Country	Name	City	State
Denmark	Department of Urology, Odense University Hospital	Odense
Denmark	Department of Urology, Roskilde Hospital	Roskilde

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	University Hospital Koge, University Hospital Roskilde

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoporosis, either T-score < -2,5 or osteoporosis fracture		2½ years	No