Table 3.
Summary of primary and secondary efficacy results for bone-turnover markers in the evaluable population
| Bone-turnover marker | Exemestane (n = 19) | Letrozole (n = 19) | Anastrozole (n = 16) | Placebo (n = 20) |
| Primary efficacy measure: percentage change from baseline to week 24* | ||||
| BAP | 3.0 (-11, 24) | -0.58 (-9.4, 7.1) | -4.5 (-7.0, 4.5) | -0.88 (-11.8, 8.1) |
| S-CTx | 21 (6.9, 34) | 31 (12, 69) | 9.3 (-7.7, 34) | 12 (-8.7, 26) |
| PINP | 24 (11, 30) | 5.7 (-1.1, 12) | 6.3 (-9.3, 19) | 6.1 (-11, 16) |
| U-CTx | 22 (10, 35) | 34 (19, 74) | 1.7 (-5.6, 29) | 15 (1.5, 29) |
| U-NTx | -8.5 (-30, 1.9) | 10 (-1.5, 20) | -1.5 (-26, 24) | 1.7 (-13, 19) |
| Secondary efficacy measure: percentage change from baseline to week 12* | ||||
| BAP | -1 (-5.7, 8.0) | -4.3 (-7.5, 7.3) | -7.3 (-17, 3.7) | -0.99 (-6.0, 3.3) |
| S-CTx | 18 (10, 37) | 18 (7.2, 39) | 8.0 (-9.6, 22) | 8.3 (2.9, 19) |
| PINP | 19 (-1.1, 34) | -0.29 (-5.9, 7.2) | 0.92 (-7.4, 7.1) | 4.1 (-12, 21) |
| U-CTx | 20 (4.7, 38) | 14 (8.4, 24) | 2.9 (-13, 9.0) | 8.8 (2.0, 13) |
| U-NTx | 6.8 (1.1, 23) | 0.21 (-12, 4.2) | -2.3 (-15, 22) | -0.36 (-13, 19) |
| Secondary efficacy measure: percentage change from baseline to week 36* | ||||
| BAP | 5.6 (3.7, 26) | 15 (1.7, 29) | 1.4 (-6.3, 6.6) | -1.9 (-10, 6.9) |
| S-CTx | 13 (-2.2, 34) | 30 (22, 52) | 9.2 (-13.5, 22) | 13 (1.2, 19) |
| PINP | 15 (-0.14, 39) | 24 (-0.33, 56) | 10 (0.47, 25) | -0.92 (-16, 22) |
| U-CTx | 17 (-5.8, 43) | 46 (26, 70) | 7.4 (-28, 29) | 23 (1.1, 39) |
| U-NTx | -6.3 (-20, 5.1) | 11 (-1.3, 34) | -1.4 (-14, 46) | 6.5 (-6, 26) |
| Secondary efficacy measure: AUC0–12 week* | ||||
| BAP, ng/ml × week | 1.6 (-2.0, 10) | -3.7 (-8.6, 2.3) | -5.8 (-26, 3.2) | -1.7 (-9.0, 5.7) |
| S-CTx, ng/ml × week | 0.68 (0.52, 1.37) | 0.60 (0.28, 0.99) | 0.33 (-0.28, 0.73) | 0.38 (0.085, 0.65) |
| PINP, ng/ml × week | 42 (25, 73) | -10 (-47, 23) | -11 (-31, 20) | 19 (-24, 56) |
| U-CTx(adjusted), μg/mmol Cr × week | 269 (-173, 553) | 302 (53, 643) | -242 (-762, 192) | 105 (-129, 396) |
| U-NTx(adjusted), nmol BCE/mmol Cr × week | 49 (-2.4, 91) | 50 (15, 81) | -6.5 (-49, 30) | 0.67 (-92, 42) |
| Secondary efficacy measure: AUC0–24 week* | ||||
| BAP, ng/ml × week | 17 (-3.7, 29) | -14 (-23, 8.1) | -14 (-55, 9.2) | 0.31 (-26, 12) |
| S-CTx, ng/ml × week | 2.0 (1.3, 2.9) | 1.5 (1.1, 2.3) | 1.0 (-0.41, 1.8) | 0.89 (0.046, 1.6) |
| PINP, ng/ml × week | 187 (95, 295) | -6.1 (-57, 79) | 19 (-46, 90) | 42 (-67, 142) |
| U-CTx(adjusted), μg/mmol Cr × week | 1063 (170, 1868) | 1157 (422, 2314) | 61 (-1077, 588) | 427 (51, 751) |
| U-NTx(adjusted), nmol BCE/mmol Cr × week | 21 (-64, 176) | 102 (-49, 210) | -9.0 (-204, 158) | -47 (-265, 58) |
*All data are medians (bias-corrected and adjusted 95% bootstrap confidence interval).
AUC, area under the curve; BAP, bone alkaline phosphatase; BCE, bone collagen equivalent; Cr, creatinine; PINP, procollagen type I N-terminal peptide; S-CTx, serum C-terminal telopeptide of type I collagen; U-CTx, urinary C-terminal telopeptide of type I collagen; U-NTx, urinary N-terminal telopeptide of type I collagen.