Table 4.

Serum findings in SDD clinical trial [37]

In the overall, intent-to-treat analysis, changes in serum biomarkers of bone resorption (ICTP and CTX), bone formation and turnover (bone-specific alkaline phosphatase and osteocalcin, respectively) were not significantly different between SDD and placebo.

In subgroup analyses:

In subjects who were postmenopausal ≤ 5 years at the baseline visit, SDD  treatment significantly reduced serum ICTP (difference in mean values [SDD  minus placebo] = −0.46 ng/ml, 95% CI: −0.71 to −0.21 ng/ml, p=0.0003) and  marginally reduced serum CTX (ratio of median values [SDD:placebo], 0.71, 95%  CI: 0.50 to 1.02, p=0.06) over two years.

In postmenopausal subjects not on significant concomitant medications, SDD  treatment significantly reduced serum ICTP (difference in mean values [SDD  minus placebo] = −0.30 ng/ml, 95% CI: −0.60 to 0.0045 ng/ml, p=0.05) and  marginally reduced serum CTX (ratio of median values [SDD:placebo], 0.75, 95%  CI: 0.56 to 1.01, p=0.06) at the two-year time point.