Table 2.
Baseline characteristics and baseline bone turnover values in the safety population
|
Mean (SD) Median (min., max.) |
||||
| Parameter | Exemestane (n = 22) | Letrozole (n = 20) | Anastrozole (n = 21) | Placebo (n = 21) |
| Baseline characteristics | ||||
| Age, years | 61 (4.7) 61 (52, 72) |
60 (4.7) 60 (47, 69) |
57 (5.1) 56 (50, 64) |
59 (4.2) 60 (52, 65) |
| Weight, kg | 69 (7.5) 70 (56, 85) |
72 (9.4) 70 (59, 95) |
66 (7.4) 68 (55, 83) |
72 (13) 73 (45, 102) |
| Height, cm | 165 (6.4) 165 (156, 178) |
162 (4.7) 163 (149, 170) |
163 (5.0) 163 (154, 172) |
164 (4.5) 164 (155, 173) |
| BMI, kg/m2 | 26 (2.8) 25 (21, 32) |
27 (3.5) 28 (22, 35) |
25 (2.9) 24 (20, 32) |
27 (4.8) 27 (18, 38) |
| Time since menopause, years | 13 (8.1) 12 (1.0, 28) |
12 (7.4) 9.0 (3.0, 25) |
12 (6.6) 8.5 (4.0, 25) |
10 (5.3) 10 (3.0, 21) |
| Baseline bone-turnover values* | ||||
| BAP, ng/ml | 16 (7.8) 13 (7.4, 38) |
12 (3.3) 11 (6.1, 19) |
16 (5.4) 16 (6.8, 25) |
14 (3.7) 14 (5.4, 19) |
| S-CTx, ng/ml | 0.51 (0.21) 0.49 (0.23, 0.94) |
0.39 (0.12) 0.41 (0.18, 0.59) |
0.54 (0.16) 0.58 (0.21, 0.79) |
0.41 (0.14) 0.39 (0.16, 0.66) |
| PINP, ng/ml | 57 (25) 55 (21, 106) |
44 (12) 41 (25, 74) |
53 (20) 51 (13, 92) |
48 (19) 45 (23, 96) |
| U-CTx, μg/mmol Cr | 289 (143) 237 (140, 725) |
234 (66) 242 (112, 358) |
338 (98) 322 (133, 550) |
256 (68) 241 (174, 383) |
| U-NTx, nmol BCE/mmol Cr |
61 (31) 55 (19, 140) |
53 (16) 55 (27, 85) |
66 (24) 63 (40, 128) |
61 (22) 54 (27, 103) |
| Baseline estrogen concentrations (pg/ml) | ||||
| E1 | 34 (15) 31 (11, 72) |
30 (11) 28 (13, 51) |
31 (12) 28 (14, 61) |
30 (11) 27 (10, 61) |
| E2 | 4.7 (2.5) 4.4 (1.1, 13) |
4.8 (2.1) 4.2 (1.8, 8.6) |
6.3 (7.0) 3.9 (1.9, 32) |
4.5 (2.1) 3.9 (1.9, 9) |
| E1S Estrone sulfate | 221 (150) 189 (58, 757) |
269 (222) 193 (79, 1075) |
252 (199) 197 (64, 896) |
274 (249) 211 (62, 1156) |
| Baseline lipid concentrations (mmol/L) | ||||
| Total cholesterol | 5.9 (0.70) 6 (5, 7) |
6.1 (0.65) 6 (5, 8) |
6.2 (0.82) 6 (4, 8) |
5.8 (0.73) 6 (4, 8) |
| LDL cholesterol | 4 (0.8) 4 (2, 6) |
4 (0.9) 4 (3, 7) |
4 (0.8) 4 (3, 6) |
4 (0.7) 4 (2, 6) |
| HDL cholesterol | 1.5 (0.41) 1.4 (0.90, 2.6) |
1.5 (0.43) 1.5 (0.87, 2.2) |
1.4 (0.39) 1.4 (0.83, 2.4) |
1.5 (0.31) 1.4 (1.1, 2.3) |
| Triglycerides | 1.4 (0.81) 1.1 (0.67, 3.7) |
1.3 (0.44) 1.2 (0.72, 2.2) |
1.3 (0.48) 1.2 (0.54, 2.5) |
1.1 (0.42) 1.0 (0.52, 2.1) |
*The baseline value was calculated as the mean of three baseline measurements.
BAP, bone alkaline phosphatase; BCE, bone collagen equivalent; BMI, body-mass index; Cr, creatinine; E1, estrone; E1S, estrone sulfate; E2, estradiol; HDL, high-density lipoprotein; LDL, low-density lipoprotein; max; min; PINP, procollagen type I N-terminal peptide; S-CTx, serum C-terminal telopeptide of type I collagen; SD, standard deviation; U-CTx, urine C-terminal telopeptide of type I collagen; U-NTx, urine N-terminal telopeptide of type I collagen.