4 mg
 Placebo
 zoledronic acid

4 mg
 Placebo
 zoledronic acid

4 mg
 Placebo
 
N
 214
 208
 214
 208
 214
 208
 
Proportion of patients with SREs (%)
 38
 49
 17
 25
 26
 33
 
p-value
 0.028
 0.052
 0.119
 
Median time to SRE (days)
 488
 321
 NR
 NR
 NR
 640
 
p-value
 0.009
 0.020
 0.055
 
Skeletal morbidity rate
 0.77
 1.47
 0.20
 0.45
 0.42
 0.89
 
p-value
 0.005
 0.023
 0.060
 
Risk reduction of suffering from multiple events** (%)
 36
 -
 NA
 NA
 NA
 NA
 
p-value
 0.002
 NA
 NA
 

* Includes vertebral and non-vertebral fractures

** Accounts for all skeletal events, the total number as well as time to each event during the trial

NR Not Reached

NA Not Applicable

Table 4: Efficacy results (solid tumours other than breast or prostate cancer)

  Any SRE (+TIH)
 Fractures*
 Radiation therapy to bone
 
  zoledronic acid

4 mg
 Placebo
 zoledronic acid

4 mg
 Placebo
 zoledronic acid

4 mg
 Placebo
 
N
 257
 250
 257
 250
 257
 250
 
Proportion of patients with SREs (%)
 39
 48
 16
 22
 29
 34
 
p-value
 0.039
 0.064
 0.173
 
Median time to SRE (days)
 236
 155
 NR
 NR
 424
 307
 
p-value
 0.009
 0.020
 0.079
 
Skeletal morbidity rate
 1.74
 2.71
 0.39
 0.63
 1.24
 1.89
 
p-value
 0.012
 0.066
 0.099
 
Risk reduction of suffering from multiple events** (%)
 30.7
 -
 NA
 NA
 NA
 NA
 
p-value
 0.003
 NA
 NA
 

* Includes vertebral and non-vertebral fractures

** Accounts for all skeletal events, the total number as well as time to each event during the trial

NR Not Reached

NA Not Applicable

In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion. The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs. The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate. Efficacy results are provided in Table 5.

Table 5: Efficacy results (breast cancer and multiple myeloma patients)

  Any SRE (+TIH)
 Fractures*
 Radiation therapy to bone
 
  zoledronic acid

4 mg
 Pam 90 mg
&nbs