. 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 3. Randomized Controlled Trials of Fracture Prevention in Prostate Cancer.

Study	Number of Patients	Study Population	Arms	Outcome
Denosumab HALT 138⁶²	1468	Castration-sensitive, current androgen-deprivation therapy; no metastases; high risk for fracture	Denosumab 60 mg versus placebo, every 6 months for 3 years	Significant increase in bone mineral density; significant 62% reduction in 3-year incidence of new vertebral fractures
Toremifene Protocol G300203⁶³	1389	Castration-sensitive, current androgen-deprivation therapy; high risk for fracture	Toremifene 80 mg daily oral versus placebo	Fewer new vertebral fractures (2.5% vs. 4.9%; P < .05); increased bone mineral density, decreased breast pain, decreased hot flashes, favorable lipid profile changes