The Current Role of Osteoclast Inhibitors in Patients with Prostate Cancer

Table 2

Main publications regarding DEN.

Reference	Study population	Treatment	End points
[11]	CS M0	DEN 60 mg vs placebo	↑ BMD in lumbar spine by 7.9%, total hip 5.7%, and distal radius 6.9% ( for all sites)
[34] HALT	CS M0	DEN 60 mg vs placebo	↓ incidence of vertebral fractures at 36 months (1.5% vs. 3.9%) (RR: 0.38; 95% CC, 0.19 to 0.78; )
[35] meta-analysis	CS M0	DEN vs ZA vs others	Similar improvement in BMD for DEN and ZA (3% hip, 3% femoral, 6% lumbar)
[36]	CR M0/high risk (PSA > 8 mg/ml or and PSA DT < 10 m)	DEN 120 mg vs placebo	↑ median bone metastasis-free survival by 4.2 m with DEN (29. 5 vs 25.2, HR: 0.85, 95% CI 0.73–0.98, ); ↑ time to first SRE (median 33.2 vs 29.5 m; HR 0·84, 95% CI: 0.71–0.98, ); No improvement of survival (43.9 m vs 44.8, HR: 1.01, 95% CI: 0.85–1.20, )
[37]	CR M+/SRE	DEN 120 mg vs ZA 40 mg	↑ time to new SRE by 20.7 m with DEN vs 17.1 m with ZA (HR: 0.82, 95% CI 0.71–0·95; )
[38]	CR M+/symptomatic skeletal events	DEN 120 mg vs ZA 4 mg	↓ risk for new SRE for DEN (HR, 0.78; 95% CI: 0.66–0.93; ); ↓ risk for any SRE for DEN (rate ratio: 0.78; 95% CI: 0.65–0.92; )