Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer

Osteoporosis Clinical Trial

Official title:

Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520052
• Other study ID #: 57/03
• Status: Completed
• Phase: N/A
• First received: August 22, 2007
• Last updated: August 22, 2007
• Start date: August 2003
• Est. completion date: August 2005

Study information

• Verified date: August 2007
• Source: Wirral University Teaching Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Wirral NHS Trust
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer

Description:

Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.

The study will also involve monitoring serum and urine bone turnover markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)

Exclusion Criteria:

• patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Prostatic Neoplasms

Intervention

Drug:
• zoledronic acid
5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)

Locations

Country	Name	City	State
United Kingdom	Wirral Hospitals Universirt NHS Trust	Upton, Wirral	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Wirral University Teaching Hospital NHS Trust	Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	axial and peripheral bone mineral density		over 3 years
Secondary	serum and urine bone turnover markers		over 1 year