Table 3.
Effect of levormeloxifene on collagen I C-telopeptide, total alkaline phosphatase, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, FSH, and LH after 35 or 56 days of treatment, expressed as % decrease from baseline (mean±s.e. mean).
| Reduction from baseline in percentage | |||||||
|---|---|---|---|---|---|---|---|
| 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* | 17 ± 6.2 | 56 ± 12 | 48 ± 10 | 56 ± 5.0 | 13 ± 5.1 | 44 ± 7.2 | 44 ± 5.3 |
| Alkaline phosphatase** | −0.9 ± 4.3 | 8.3 ± 2.7 | 11 ± 6.1 | 25 ± 2.3 | 4.5 ± 1.7 | 31 ± 2.6 | 29 ± 3.5 |
| Triglycerides*** | 0.3 ± 14 | −15 ± 10 | −19 ± 7.0 | 2.1 ± 13 | −10 ± 7.9 | 2.1 ± 7.1 | −3.5 ± 5.4 |
| Total cholesterol** | 0.6 ± 1.7 | 20 ± 3.4 | 24 ± 4.7 | 25 ± 3.9 | −3.7 ± 3.4 | 23 ± 3.9 | 23 ± 2.5 |
| LDL-cholesterol** | 0.8 ± 5.0 | 30 ± 6.0 | 35 ± 5.8 | 32 ± 4.5 | −4.0 ± 4.6 | 32 ± 4.9 | 32 ± 3.1 |
| HDL-cholesterol*** | −0.0 ± 3.0 | −9.8 ± 5.3 | −14 ± 3.7 | −15 ± 3.3 | −0.6 ± 3.9 | 11 ± 3.7 | 9.8 ± 5.0 |
| FSH** | −1.5 ± 5.7 | 45 ± 6.8 | 34 ± 11 | 49 ± 4.6 | 6.0 ± 2.7 | 55 ± 4.7 | 54 ± 5.8 |
| LH** | −6.8 ± 15 | 48 ± 7.4 | 42 ± 8.6 | 41 ± 9.7 | −5.7 ± 4.7 | 62 ± 8.6 | 49 ± 6.7 |
*
statistical significant difference between active and placebo after 56 days of treatment, P = 0.015, F-test with 2 d.f., overall percentage reduction for active treatment compared with placebo: 44.4% [95% CI: 11.3, 65.1] in Part 1 and 35.5% [95% CI: 14.0, 51.6] in Part 2.
**
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.