A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory Metastatic Prostate Carcinoma
Hôpital Notre-Dame · London Health Sciences Centre · +4 more institutions
Abstract
Bone metastases are a common cause of morbidity in patients with prostate carcinoma. We studied the effect of a new bisphosphonate, zoledronic acid, which blocks bone destruction, on skeletal complications in prostate cancer patients with bone metastases.
Patients with hormone-refractory prostate cancer and a history of bone metastases were randomly assigned to a double-blind treatment regimen of intravenous zoledronic acid at 4 mg (N = 214), zoledronic acid at 8 mg (subsequently reduced to 4 mg; 8/4) (N = 221), or placebo (N = 208) every 3 weeks for 15 months. Proportions of patients with skeletal-related events, time to the first skeletal-related event, skeletal morbidity rate, pain and analgesic scores, disease progression, and safety were assessed. All statistical tests were two-sided.
Citation impact
- FWCI
- 41.66
- Percentile
- 100%
- References
- 52
Authors
10- FSFred SaadCorresponding
Hôpital Notre-Dame, London Health Sciences Centre, Hôtel-Dieu de Québec, Advanced Pharma, Peter MacCallum Cancer Centre, Centre Hospitalier de l’Université de Montréal
- DMDonald M. Gleason
Centre Hospitalier de l’Université de Montréal, Advanced Pharma, Hôtel-Dieu de Québec, Peter MacCallum Cancer Centre, London Health Sciences Centre, Hôpital Notre-Dame
- RMRobin Murray
Centre Hospitalier de l’Université de Montréal, Hôtel-Dieu de Québec, London Health Sciences Centre, Peter MacCallum Cancer Centre, Hôpital Notre-Dame, Advanced Pharma
- STS. Tchekmedyian
London Health Sciences Centre, Advanced Pharma, Hôtel-Dieu de Québec, Hôpital Notre-Dame, Centre Hospitalier de l’Université de Montréal, Peter MacCallum Cancer Centre
- PVP. Venner
Hôtel-Dieu de Québec, Advanced Pharma, Hôpital Notre-Dame, Centre Hospitalier de l’Université de Montréal, London Health Sciences Centre, Peter MacCallum Cancer Centre
Topics & keywords
- Zoledronic acid
- Medicine
- Oncology
- Placebo
- Internal medicine
- Randomized controlled trial
- Refractory (planetary science)
- Prostate carcinoma
- Good health and well-being