Table 1.

Selected baseline disease characteristics

CharacteristicZoledronic acid 4 mg i.v. Q4W N = 1,020Denosumab 120 mg s.c. Q4W N = 1,026
Age, y, median (Q1, Q3)56 (49, 65)57 (48, 65)
Postmenopausal status, n (%)831 (82)839 (82)
ECOG status, n (%)
 0488 (48)504 (49)
 1444 (44)451 (44)
 282 (8)68 (7)
Time from primary cancer diagnosis to initial diagnosis of bone metastases, median (Q1, Q3)35 (9, 75)33 (7, 79)
Presence of visceral metastases, n (%)525 (51)552 (54)
Prior SREs, n (%)a
 No prior SREs647 (63)648 (63)
 One or more prior SREs373 (37)378 (37)
Prior radiation therapy to bone, n (%)280 (28)258 (25)
Pain scores on BPI-SF, n (%)b
No or mild pain (0–4)500 (49)542 (53)
Moderate or severe pain (>4)451 (44)433 (42)
FACT-G total score, median (Q1, Q3)c74 (61, 86)74 (61, 85)

Abbreviations: Q4W, every 4 weeks; Q1, first quartile; Q3, third quartile.

  • aBased on randomization stratification.

  • bBPI-SF scores range from 0 to 10, with a higher score indicating greater pain severity. Baseline BPI-SF data were missing for 69 patients (7%) of patients in the zoledronic acid group and 51 patients (5%) in the denosumab group; these patients were not included in the HRQoL analyses.

  • cFACT-G total score ranges from 0 to 108.