Solid Tumors –PC/BCTotal Number of SREs (011)

With 21-day window Without 21-day window

ZOMETA® ZOMETA 4 mg Placebo 4 mg Placebo

SRE (+HCM) 131 163 201 275

SRE 131 156 201 267

Pathologic fracture 48 63 69 95

Vertebral fracture 21 32 27 41

Nonvertebral fracture 31 34 42 54

Radiation to bone 79 101 112 153

Surgery to bone 12 9 12 9

Spinal cord compression 7 10 8 10

Hypercalcemia 0 8 0 8

56

Pro 011 PTT 9.2-6xx

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