Table 4.
Mean of baseline and mean of absolute change in collagen I C-telopeptide, total alkaline phosphatase, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, FSH, and LH after 35 or 56 days of treatment with levomeloxifene.
Baseline values and absolute change from baseline | |||||||
---|---|---|---|---|---|---|---|
Day 35 (Part 1) | Day 56 (Part 2) | ||||||
Placebo (n = 6) | 20 mg (n = 6) | 80 mg (n = 6) | 160 mg (n = 6) | Placebo (n = 8) | 40 mg (n = 12) | 80 mg (n = 12) | |
C-telopeptide* (µg mmol−1) | 365 | 250 | 379 | 313 | 333 | 441 | 321 |
−25.1 | −135 | −191 | −166 | −50.6 | −208 | −139 | |
Alkaline phosphatase** (U l−1) | 66.3 | 66.3 | 61.8 | 85.5 | 62.4 | 78.2 | 72.3 |
0.6 | −5.2 | −6.6 | −21.7 | −2.8 | −24.3 | −21.3 | |
Triglycerides*** (mmol l−1) | 1.33 | 1.17 | 0.99 | 1.53 | 1.09 | 1.54 | 1.19 |
0.00 | 0.18 | 0.20 | −0.03 | 0.11 | −0.03 | −0.04 | |
Total cholesterol** (mmol l−1) | 6.18 | 5.53 | 5.70 | 6.55 | 5.74 | 6.13 | 6.10 |
−0.04 | −1.12 | −1.32 | −1.62 | 0.21 | −1.41 | −1.37 | |
LDL-cholesterol** (mmol l−1) | 4.23 | 3.47 | 3.60 | 4.37 | 3.44 | 3.84 | 3.84 |
−0.03 | −1.05 | −1.19 | −1.39 | 0.14 | −1.23 | −1.23 | |
HDL-cholesterol*** (mmol l−1) | 1.35 | 1.53 | 1.65 | 1.48 | 1.81 | 1.59 | 1.73 |
0.00 | −0.15 | −0.22 | −0.22 | 0.01 | −0.17 | −0.17 | |
FSH** (IU l−1) | 66.4 | 59.3 | 67.7 | 72.0 | 63.7 | 77.2 | 85.0 |
1.00 | −26.7 | −23.4 | −35.6 | −3.83 | −42.3 | −45.5 | |
LH** (IU l−1) | 25.9 | 27.3 | 35.2 | 23.6 | 24.2 | 39.3 | 30.9 |
1.82 | −13.2 | −15.5 | −9.78 | 0.64 | −21.3 | −12.5 |
statistical significant difference between active and placebo after 56 days of treatment, P < 0.015, F-test with 2 d.f.
statistical significant difference between active and placebo after 35 days and after 56 days of treatment, P < 0.05.
not statistically significant after 35 days nor after 56 days of treatment, P > 0.05.