Table 4. Changes in femur/spine BMD compared to the baseline in the intention-to-treat population during letrozole treatment.
BMD | Baseline* | Months | p-value | ||
---|---|---|---|---|---|
12 | 24 | 36 | |||
Femur BMD | |||||
Total | |||||
N | 891 | 751 | 645 | 288 | < 0.0001† |
Mean | −0.21 | −0.38 | −0.52 | −0.46 | < 0.0001‡ |
SD | 1.07 | 1.09 | 1.03 | 0.93 | 0.0031§ |
p-valueII | - | < 0.0001 | < 0.0001 | < 0.0001 | |
Calcium | - | ||||
N | 165 | 144 | 134 | 52 | 0.3707¶ |
Mean | −0.49 | −0.66 | −0.88 | −0.69 | < 0.0001** |
SD | 1.12 | 1.13 | 1.02 | 0.97 | 0.0066§ |
p-valueII | - | < 0.0001 | < 0.0001 | 0.0001 | |
Non-calcium | |||||
N | 726 | 607 | 511 | 236 | < 0.0001‡ |
Mean | −0.14 | −0.32 | −0.43 | −0.41 | |
SD | 1.05 | 1.07 | 1.02 | 0.92 | |
p-valueII | - | < 0.0001 | < 0.0001 | < 0.0001 | |
Spine BMD | |||||
Total | |||||
N | 887 | 752 | 644 | 286 | < 0.0001‡ |
Mean | −0.44 | −0.76 | −0.92 | −0.84 | < 0.0001‡ |
SD | 1.16 | 1.21 | 1.13 | 1.06 | < 0.0001§ |
p-valueII | - | < 0.0001 | < 0.0001 | < 0.0001 | |
Calcium | |||||
N | 162 | 145 | 134 | 51 | 0.1060¶ |
Mean | −0.79 | −1.09 | −1.36 | −1.25 | < 0.0001** |
SD | 1.06 | 1.10 | 0.97 | 1.00 | 0.0010§ |
p-valueII | - | < 0.0001 | < 0.0001 | 0.0001 | |
Non-calcium | |||||
N | 725 | 607 | 510 | 235 | < 0.0001§ |
Mean | −0.36 | −0.69 | −0.81 | −0.75 | |
SD | 1.17 | 1.23 | 1.14 | 1.05 | |
p-valueII | - | < 0.0001 | < 0.0001 | 0.0001 |
BMD=bone mineral density; SD=standard deviation.
*p=0.0001 for equality of mean baseline femur/spine BMD between the calcium and non-calcium groups using the Student t-test; †For equality of mean femur/spine BMD across visits using the generalized estimating equation (GEE); ‡For a linear trend test of mean femur/spine BMD across visits using GEE analysis; §For a quadratic trend test of mean femur/spine BMD across visits using GEE analysis; ∥For comparisons of mean femur/spine BMD changes between baseline and each follow-up visit using contrasts within the GEE; ¶For an interaction effect between the calcium/non-calcium group and visits using the GEE; **For overall equality of mean femur/spine BMD between the calcium and non-calcium groups using the GEE.