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. Author manuscript; available in PMC: 2011 May 10.
Published in final edited form as: Lancet. 2011 Feb 25;377(9768):813–822. doi: 10.1016/S0140-6736(10)62344-6

Table 5.

Studies of antiresorptive drugs for the prevention of skeletal-related events in castration-resistant prostate cancer

Drugs studied Study
duration
(months)
Patients with skeletal-
related events
Median time to first
skeletal-related event
(months)
Time to first and
subsequent
skeletal-related events
Saad et al (2004)5 Zoledronic acid (n=214) vs placebo (n=208) 24* 81 (38%) vs 101 (49%); p=0·028 16·0 vs 10·5; p=0·009 HR 0·64 (95% CI 0·485–0·845); p=0·002
Small et al (2003)19 Pamidronic acid (n=169) vs placebo (n=181) 6·8 42 (25%) vs 46 (25%); p value not reported Not tested Not tested
Fizazi et al (2011) Denosumab (n=950) vs zoledronic acid (n=951) 41 341 (36%) vs 386 (41%) 20·7 (95% CI 18·8–24·9) vs 17·1 (15·0–19·4); p=0·0002 (non-inferiority), p=0·008 (superiority)§ RR 0·82 (95% CI 0·71–0·94); p=0·008§

n=number of patients. HR=hazard ratio. RR=rate ratio.

*

Fixed interval study with maximum of 24 months’ treatment duration.

Fixed interval study with maximum of 27 weeks’ treatment duration.

Event-driven study with maximum of 41 months’ treatment duration.

§

All randomised patients; p values were adjusted for multiplicity.