Table 1.
Patient baseline demographics and disease characteristics (ITT).
| Total (N=397) | PC (n=299) | BC (n=98) | |
|---|---|---|---|
| Median age, years (range) | 70 (30–85) | 71 (48–85) | 61 (30–82) |
| Sex, n (%) | |||
| Male | 299 (75.3) | 299 (100) | 0 |
| Female | 98 (24.7) | 0 | 98 (100) |
| Race, n (%) | |||
| Caucasian | 383 (96.5) | 292 (97.7) | 91 (92.9) |
| Asian | 1 (0.3) | 0 | 1 (1.0) |
| Other | 13 (3.3) | 7 (2.3) | 6 (6.1) |
| Prior therapy, n (%) | |||
| Radiation | 129 (32.5) | 75 (25.1) | 54 (55.1) |
| Chemotherapy | 133 (33.5) | 65 (21.7) | 68 (69.4) |
| Hormone therapy | 342 (86.1) | 270 (90.3) | 72 (73.5) |
| Chemo- and hormone therapy | 111 (28) | 61 (20.4) | 50 (51.0) |
| Surgery | 215 (54.2) | 133 (44.2) | 82 (82.8) |
| Mean time from diagnosis to study entry, days (SD) | 155.4 (366.4) | 174.3 (382.2) | 97.7 (308.0) |
| Extent of bone disease, n (%) | |||
| Normal bone scan | 3 (0.8) | 2 (0.7) | 1 (1.0) |
| <6 Bone lesions | 195 (49.1) | 131 (43.8) | 64 (65.3) |
| 6–20 Bone lesions | 118 (29.7) | 93 (31.1) | 25 (25.5) |
| >20 Bone lesions but<super scan | 54 (13.6) | 48 (16.1) | 6 (6.1) |
| Super scan (75% of ribs, vertebrae, and pelvic bones have lesions) | 24 (6.0) | 23 (7.7) | 1 (1.0) |
| Sites of extraskeletal metastases, n (%) | |||
| Lung | 35 (8.8) | 12 (4) | 23 (23.5) |
| Liver | 24 (6.0) | 4 (1.3) | 20 (20.4) |
| Lymph nodes | 98 (24.7) | 80 (26.8) | 18 (18.4) |
| Other | 19 (4.8) | 10 (3.3) | 9 (9.2) |
| Soft tissue | 6 (1.5) | 3 (1.0) | 3 (3.1) |
| Not evaluated | 251 (63.2) | 207 (69.2) | 44 (44.9) |
| Bone turnover marker levels, mean (SD) | (n=387) | (n=294) | (n=93) |
| P1NP (ng/mL) | 227.1 (409.5) | 268 (458.8) | 97.9 (104) |
| CTX (ng/mL) | 0.5 (0.53) | 0.5 (0.58) | 0.3 (0.28) |
| OPG (pmol/L) | 5.6 (2.2) | 5.8 (2.4) | 5.1 (1.7) |
| RANKL (pmol/L) | 0.1 (0.27) | 0.1 (0.29) | 0.1 (0.20) |
| PSA levels, mean (SD) | (n=294) | (n=294) | N/A |
| PSA (μg/L) | 168.5 (531.1) | 168.5 (531.1) | N/A |
BC, breast cancer; CTX, serum C-terminal cross-linking telopeptide of type I collagen; ITT, intent-to-treat population; N/A, not applicable; OPG, osteoprotegerin; P1NP, amino-terminal propeptide of type I collagen; PC, prostate cancer; PSA, prostate-specific antigen; RANKL, receptor activator of nuclear factor-κB ligand; SD, standard deviation.