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Summary of primary and secondary efficacy results for bone-turnover markers in the evaluable population |
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| Bone-turnover marker |
Exemestane (n = 19) |
Letrozole (n = 19) |
Anastrozole (n = 16) |
Placebo (n = 20) |
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| Primary efficacy measure: percentage change from baseline to week 24* |
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| 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* |
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| 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* |
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| 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* |
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| 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* |
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| 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) |
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*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. | ||||
Goss et al. Breast Cancer Research 2007 9:R52 doi:10.1186/bcr1757 |
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