Phase II Trial of Zometa on Bone Mineral Density on Patients With Stage D Prostate Cancer Undergoing Androgen Ablation Therapy
Castration by GnRH agonist therapy with or without androgen antagonists has been a mainstay
for advanced prostate cancer. One of the most significant side effects of the use of
androgen ablative therapies has been a decrease in bone mineral density, potentially placing
patients at greater risk of osteoporosis and bone fractures. It is prudent to anticipate
this adverse effect of therapy and to minimize its severity with appropriate and timely
pharmacologic intervention. Zometa is a bisphosphonates and bisphosphonates are effective
inhibitors of osteoclastic bone resorption. Recent studies have shown that other
bisphosphonates were able to reduce the bone loss observed after 24 and 48 weeks of
treatment with a GnRH analogue. An unanswered question remains, however, in how frequently
these agents should be employed in clinical practice.
This is a three-arm randomized trial of Zometa® on bone mineral density in subjects with
stage D prostate cancer undergoing androgen ablation therapy. If subjects are enrolled in
Arm 1, the GnRH analogue would be administered every 3 months for 1 year. Four milligrams of
Zometa® would be administered IV over 15 minutes 7 days prior to beginning androgen
deprivation therapy. If subjects are enrolled in Arm 2, the GnRH analogue would be
administered every 3 months for one year, and 4 mg of Zometa® would be administered IV over
15 minutes at month 6. If subjects are enrolled in Arm 3, the GnRH analogue is administered
every 3 months for 1 year, with 4 mg of Zometa® administered IV over 15 minutes monthly for
6 months, beginning at month 6.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the effect of timing of Zometa administration on bone mineral density of the lumbar spine and femoral neck in men undergoing androgen deprivation therapy for prostate adenocarcinoma .
2 years
No
Douglas McNeel, MD
Principal Investigator
University of Wisconsin, Madison
United States: Institutional Review Board
CO02807
NCT00582556
April 2003
March 2013
Name | Location |
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University of Wisconsin | Madison,, Wisconsin 53792-5666 |