Table 3.
Differences in bone biomarker values at last postbaseline assessment according to key baseline patient or treatment characteristics.
| Bone metastases |
Prior AR treatment |
Concomitant AR treatment |
Prior bone radiation |
Prior fracture |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Without | With | Without | With | Without | With | Without | With | Without | With | ||
| CTX (ng/ml) | n | 82 | 121 | 152 | 51 | 72 | 131 | 157 | 46 | 195 | 8 |
| Mean (SD) | 0.14 (0.13) | 0.13 (0.12) | 0.14 (0.12) | 0.11 (0.13) | 0.18 (0.14) | 0.11 (0.10) | 0.14 (0.13) | 0.11 (0.09) | 0.13 (0.12) | 0.11 (0.10) | |
| Median (range) | 0.10 (0.01‒0.65) |
0.10 (0.01‒0.72) |
0.10 (0.01‒0.65) |
0.07 (0.02‒0.72) |
0.14 (0.01‒0.65) |
0.08 (0.01‒0.72) |
0.10 (0.01‒0.72) |
0.09 (0.01‒0.45) |
0.10 (0.01‒0.72) |
0.06 (0.03‒0.32) |
|
| P-valuea | 0.375 | 0.009 | < 0.001 | 0.372 | 0.446 | ||||||
| Osteocalcin (ng/ml) |
n | 82 | 126 | 156 | 52 | 73 | 135 | 161 | 47 | 200 | 8 |
| Mean (SD) | 9.76 (6.85) | 10.13 (9.15) | 9.68 (6.38) | 10.89 (12.47) | 10.54 (7.07) | 9.69 (8.92) | 9.97 (8.54) | 10.05 (7.52) | 10.08 (8.44) | 7.48 (3.14) | |
| Median (range) | 7.76 (1.28‒42.49) | 7.81 (1.00‒77.90) | 7.97 (1.28‒42.49) | 7.56 (1.00‒77.90) |
7.86 (2.31‒42.49) | 7.81 (1.00‒77.90) | 7.67 (1.00‒77.90) | 8.40 (2.33‒43.87) |
7.81 (1.00‒77.90) | 6.98 (3.26‒11.46) |
|
| P-valuea | 0.902 | 0.373 | 0.200 | 0.556 | 0.498 | ||||||
| P1NP (ng/ml) | n | 81 | 126 | 155 | 52 | 72 | 135 | 160 | 47 | 199 | 8 |
| Mean (SD) | 54.86 (59.78) | 63.91 (67.78) | 59.98 (63.40) | 61.53 (69.33) | 55.50 (49.13) | 62.97 (71.77) | 57.12 (61.44) | 71.44 (74.67) | 61.19 (65.62) | 39.80 (34.24) | |
| Median (range) | 37.17 (9.22‒458.20) | 37.12 (6.20‒323.30) | 38.34 (6.20‒458.20) | 34.00 (11.52‒302.80) | 39.09 (6.20‒302.80) | 36.06 (9.22‒458.20) | 37.06 (6.20‒458.20) | 38.41 (11.52‒323.30) | 37.60 (6.20‒458.20) | 29.97 (12.66‒114.30) | |
| P-valuea | 0.999 | 0.500 | 0.475 | 0.505 | 0.283 | ||||||
| PTH (pg/ml) | n | 83 | 126 | 157 | 52 | 73 | 136 | 162 | 47 | 201 | 8 |
| Mean (SD) | 42.64 (56.54) | 40.43 (41.57) | 44.15 (49.65) | 32.74 (41.69) | 35.81 (28.91) | 44.26 (55.43) | 40.37 (41.82) | 44.54 (65.30) | 42.12 (48.68) | 20.99 (12.30) | |
| Median (range) | 29.49 (3.65‒447.50) | 29.00 (1.36‒289.50) | 30.40 (2.78‒447.50) | 23.75 (1.36‒289.50) | 28.45 (1.36‒119.00) | 29.67 (2.78‒447.50) | 28.59 (1.36‒289.50) | 30.70 (6.63‒447.50) | 29.49 (1.36‒447.50) | 21.93 (3.20‒33.26) |
|
| P-value a | 0.914 | 0.034 | 0.560 | 0.581 | 0.145 | ||||||
| 25-OH-vitamin D (ng/ml) | n | 82 | 125 | 155 | 52 | 72 | 135 | 160 | 47 | 200 | 7 |
| Mean (SD) | 21.10 (13.06) | 22.85 (14.81) | 21.80 (13.93) | 23.20 (14.82) | 19.21 (12.68) | 23.72 (14.66) | 22.42 (14.18) | 21.24 (14.10) | 22.11 (14.01) | 23.45 (18.64) | |
| Median (range) | 17.53 (4.08‒57.75) | 18.90 (3.40‒69.64) | 18.15 (3.40‒69.64) | 21.50 (3.65‒69.44) |
16.48 (3.40‒69.64) | 21.21 (3.91 ‒69.44) |
18.53 (3.65‒69.44) | 17.59 (3.40‒69.64) |
18.15 (3.40‒69.64) | 19.84 (8.30‒62.76) |
|
| P-value a | 0.461 | 0.542 | 0.029 | 0.551 | 0.987 | ||||||
Abbreviations: 25-OH-vitamin D, 25-hydroxyvitamin D; AR, antiresorptive; CTX, C-terminal cross-linking telopeptide of type 1 collagen; P1NP, procollagen type 1 N-terminal peptide; PTH, parathyroid hormone; SD, standard deviation.
a
P-values for differences in last postbaseline assessment values for each biomarker were established using the Wilcoxon rank-sum test. Statistical significance was accepted when P < 0.05 (bold text).