Table 3.

Efficacy and safety data from the phase III trials comparing denosumab versus zoledronic acid in patients with genitourinary malignancies.

Endpoint	CRPC [Fizazi et al. 2011; Henry et al. 2011]	Multiple myeloma or solid tumors (including RCC and bladder cancer) [Fizazi et al. 2011; Henry et al. 2011]
Efficacy
Median time to first SRE	20.7 months (denosumab) versus 17.1 months (ZOL); p=0.008 for superiority	20.6 months (denosumab) versus 16.3 months (ZOL); p=0.06 for superiority
Cumulative risk of SREs	HR = 0.82; p=0.008 for denosumab versus ZOL	HR = 0.90; p=0.14 for denosumab versus ZOL
Safety*
Acute-phase reactions	8% (denosumab) versus 18% (ZOL); p not reported	6.9% (denosumab) versus 14.5% (ZOL); p<0.001
Hypocalcemia	13% (denosumab) versus 6% (ZOL); p<0.0001	10.8% (denosumab) versus 5.8% (ZOL); p not reported
Renal adverse events	15% (denosumab) versus 16% (ZOL); p not reported	8.3% (denosumab) versus 10.9% (ZOL): p=0.07
Osteonecrosis of the jaw	2% (denosumab) versus 1% (ZOL); p=0.09	1.3% (denosumab) versus 1.1% (ZOL); p=1.00

^*Only AEs of interest based on known safety profiles of the two agents are presented.

Abbreviations: CRPC, castration-resistant prostate cancer; HR, hazard ratio; RCC, renal cell carcinoma.