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Intent-to-treat subjects All active treatment groups showed significant differences from placebo in each of the 4 BMD endpoints at cycles 6, 13, 19, and 26. The mean percent increases in the primary efficacy measure (L2 to L4 BMD) at the final on-therapy evaluation (cycle 26 for those who completed and the last available evaluation for those who discontinued early) were 2.46% with 0.625 mg, 2.26% with 0.45 mg, and 1.13% with 0.3 mg. The placebo group showed a mean percent decrease from baseline at the final evaluation of 2. 45%. These results show that the lower dosages of Premarin were effective in increasing L2 to L4 BMD compared with placebo and, therefore, support the efficacy of the lower doses. The analysis for the other 3 BMD endpoints yielded mean percent changes from baseline in femoral trochanter that were generally larger than those seen for L2 to L4 and changes in femoral neck and total body that were generally smaller than those seen for L2 to L4. Significant differences between groups indicated that each of the Premarin treatments was more effective than placebo for all 3 of these additional BMD endpoints. Text Continues Below
With regard to femoral neck and total body, the active treatment groups all showed mean percent increases in BMD while placebo treatment was accompanied by mean percent decreases. For femoral trochanter, each of the Premarin dose groups showed a mean percent increase that was significantly greater than the small increase seen in the placebo group. The percent changes from baseline to final evaluation are shown in Table 3. TABLE 3. PERCENT CHANGE IN BONE MINERAL DENSITY: COMPARISON BETWEEN ACTIVE AND PLACEBO GROUPS IN THE INTENT-TO-TREAT POPULATION, LAST OBSERVATION CARRIED FORWARD
Region Evaluated
Treatment Group a
No. of
Subjects
Baseline (g/ cm 2 )
Mean ± SD
Change from Baseline (%)
Adjusted Mean ± SE
p-Value vs
Placebo
L2 to L4 BMD
0.625 83 1.17 ± 0.15 2.46 ± 0.37 < 0.001
0.45 91 1.13 ± 0.15 2.26 ± 0.35 < 0.001
0.3 87 1.14 ± 0.15 1.13 ± 0.36 < 0.001
Placebo 85 1.14 ± 0.14 -2.45 ± 0.36 Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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