Abstract | PURPOSE: METHODS: We randomized 93 patients with M0 prostate cancer in this placebo controlled trial in the Veterans Affairs health care system. Preplanned strata included 50 patients on androgen deprivation therapy for less than 1 year (stratum 1) and 43 on androgen deprivation therapy for greater than 1 year (stratum 2). In each stratum patients were randomized to 4 mg zoledronic acid intravenously every 3 months for 4 treatments or intravenous placebo. The primary end point was the percent change in bone mineral density at the lumbar spine at 12 months. RESULTS: Age, race, body mass index and osteoporosis risk factors were similar for the 2 treatments. Most patients were former smokers, had moderate alcohol intake, were not on calcium/ vitamin D supplements and were relatively sedentary at baseline. In stratum 1 spine bone mineral density increased 5.95% in the zoledronic acid arm and decreased 3.23% in the placebo arm (p = 0.0044). In stratum 2 spine bone mineral density increased 6.08% in the zoledronic acid arm and only increased 1.57% in the placebo arm (p = 0.0005). Treatment was well tolerated with minimal impact on renal function. CONCLUSIONS:
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Authors | Nirmala Bhoopalam, Steven C Campbell, Thomas Moritz, William R Broderick, Padmini Iyer, Anthony G Arcenas, Peter J Van Veldhuizen, Nicholas Friedman, Domenic Reda, Stuart Warren, Harinder Garewal |
Journal | The Journal of urology
(J Urol)
Vol. 182
Issue 5
Pg. 2257-64
(Nov 2009)
ISSN: 1527-3792 [Electronic] United States |
PMID | 19758618
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androgen Antagonists
- Bone Density Conservation Agents
- Diphosphonates
- Imidazoles
- Zoledronic Acid
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Topics |
- Aged
- Androgen Antagonists
(adverse effects, therapeutic use)
- Bone Density Conservation Agents
(administration & dosage)
- Diphosphonates
(administration & dosage)
- Humans
- Imidazoles
(administration & dosage)
- Infusions, Intravenous
- Male
- Osteoporosis
(chemically induced, prevention & control)
- Prostatic Neoplasms
(drug therapy)
- Risk Factors
- Veterans
- Zoledronic Acid
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