. Author manuscript; available in PMC: 2011 May 10.

Published in final edited form as: Clin Genitourin Cancer. 2010 Dec 1;8(1):29–36. doi: 10.3816/CGC.2010.n.005

Table 1. Randomized Controlled Trials of Osteoclast-Targeted Therapies in Prostate Cancer Metastatic to Bone.

Study	Number of Patients	Study Population	Arms	Outcome
Zometa 039³³,⁴⁵	643	Castration-resistant, asymptomatic or minimally symptomatic	4 mg zoledronic acid versus placebo, every 3 weeks for 15 months	Significant decrease in SREs (33.2% vs. 44.2%); trend toward improved survival; established zoledronic acid as standard of care in this setting
CGP 032/INT 05⁴⁶	350	Castration-resistant, symptomatic	90 mg pamidronate versus placebo, every 3 weeks for 27 weeks	No significant difference in pain, analgesic use, or SREs
NCIC CTG Pr.6⁴⁷	209	Castration-resistant, symptomatic	Mitoxantrone and prednisone ± 1500 mg clodronate, every 3 weeks until progression	No significant difference in palliative response, duration of response, progression-free survival, overall survival, overall quality of life
Denosumab protocol 20050103⁴⁸	1901	Castration-resistant	120 mg denosumab versus 4 mg zoledronic acid, every 4 weeks	Denosumab was superior to zoledronic acid; no difference in overall survival or adverse event rates
MRC PR05⁴⁹,⁵⁰	311	Castration-sensitive	2080 mg daily oral clodronate versus placebo, for 3 years maximum	Trend toward improved bone progression-free survival (P = .066); significantly improved 8-year overall survival (22% vs. 14%; HR, 0.077; P = .032)
CALGB/CTSU 90202	680^a	Castration-sensitive	4 mg zoledronic acid versus placebo, every 4 weeks until progression to CRPC or first SRE, then cross over to open label	Ongoing Primary endpoint: SRE or prostate cancer death

Targeted accrual.

Abbreviations: CRPC = castrate-resistant prostate cancer; SRE = skeletal-related events