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 Total Body BMD 0.625 84 1.15 ± 0.08 0.68 ± 0.17 < 0.001 0.45 91 1.14 ± 0.08 0.74 ± 0.16 < 0.001 0.3 87 1.14 ± 0.07 0.40 ± 0.17 < 0.001 Placebo 85 1.13 ± 0.08 -1.50 ± 0.17 Femoral Neck BMD 0.625 84 0.91 ± 0.14 1.82 ± 0.45 < 0.001 0.45 91 0.89 ± 0.13 1.84 ± 0.44 < 0.001 0.3 87 0.86 ± 0.11 0.62 ± 0.45 < 0.001 Placebo 85 0.88 ± 0.14 -1.72 ± 0.45 Femoral Trochanter BMD 0.625 84 0.78 ± 0.13 3.82 ± 0.58 < 0.001 0.45 91 0.76 ± 0.12 3.16 ± 0.56 0.003 0.3 87 0.75 ± 0.10 3.05 ± 0.57 0.005 Placebo 85 0.75 ± 0.12 0.81 ± 0.58 a: Identified by dosage (mg) of Premarin or placebo. Figure 1 shows the cumulative percentage of subjects with changes from baseline equal to or greater than the value shown on the x-axis. Figure 1. CUMULATIVE PERCENT OF SUBJECTS WITH CHANGES FROM BASELINE IN SPINE BMD OF GIVEN MAGNITUDE OR GREATER IN PREMARIN AND PLACEBO GROUPS The mean percent changes from baseline in L2 to L4 BMD for women who completed the bone density study are shown with standard error bars by treatment group in Figure 2. Significant differences between each of the Premarin dosage groups and placebo were found at cycles 6, 13, 19, and 26. Figure 2. ADJUSTED MEAN (SE) PERCENT CHANGE FROM BASELINE AT EACH CYCLE IN SPINE BMD: SUBJECTS COMPLETING IN PREMARIN GROUPS AND PLACEBO The bone turnover markers serum osteocalcin and urinary N-telopeptide significantly decreased (p 0.001) in all active-treatment groups at cycles 6, 13, 19, and 26 compared with the placebo group. Larger mean decreases from baseline were seen with the active groups than with the placebo group. Significant differences from placebo were seen less frequently in urine calcium. | ||||
Email this article
Printer friendly
Bookmark this pageadvertisement
