Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
N/A
N/A
Male
Osteoporosis
Trial Information
Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
axial and peripheral bone mineral density
Outcome Time Frame:
over 3 years
Principal Investigator
Nigel J Parr, MBBS, FRCS, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wirral Hospital University NHS Trust
Authority:
United Kingdom: Wirral NHS Trust
Study ID:
57/03
NCT ID:
NCT00520052
Start Date:
August 2003
Completion Date:
August 2005
Related Keywords:
- Osteoporosis
- bisphosphonates, prostate cancer, bone density, osteoporosis
- Osteoporosis
- Prostatic Neoplasms
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