APPENDIX TABLE 4.
BASELINE | 6 MONTHS | 12 MONTHS | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Mean (SD) | minimum-maximum | Mean Change * | 95% CI | P Value MK-677 vs. Placebo † | Mean Change * | 95% CI | P Value MK-677 vs. Placebo † | |||
BONE MINERAL DENSITY | ||||||||||
Femoral Neck, g/cm2 | Placebo | N=22 | 0.752 (0.137) | 0.584-1.101 | 0.010 | -0.001-0.021 | 0.012 | 0.002-0.022 | ||
MK-677 | N=43 | 0.748 (0.133) | 0.522-1.066 | -0.003 | -0.011-0.005 | 0.079 | -0.005 | -0.01-0.002 | 0.004 | |
Spine [L2-L4], g/cm2 | Placebo | N=22 | 1.046 (0.164) | 0.770-1.441 | 0.004 | -0.013-0.022 | 0.005 | -0.010-0.020 | ||
MK-677 | N=43 | 1.085 (0.196) | 0.761-1.630 | 0.001 | -0.012-0.013 | >.99 | 0.008 | -0-0.019 | 0.69 | |
Total Hip, g/cm2 | Placebo | N=22 | 0.910 (0.160) | 0.688-1.315 | 0.005 | -0.003-0.014 | 0.005 | -0.003-0.013 | ||
MK-677 | N=43 | 0.896 (0.138) | 0.686-1.183 | -0.002 | -0.008-0.004 | 0.22 | -0.004 | -0.01-0.002 | 0.063 |
Baseline data presented are the arithmetic mean (SD) and the minimum and maximum values
Mean change (arithmetic difference) from baseline with 95% confidence limits at 6 months and at 12 months
P values are for the pivotal comparisons between the two groups at 6 months and at 12 months.
Bone mineral density was determined by DXA.