Figure 2.

Changes in bone turnover marker levels at 6 and 12 weeks vs baseline in the overall population. The percentage change in bone turnover marker levels was calculated from the differences at 6 and 12 weeks vs baseline (investigator-assessed, protocol-specified exploratory endpoint). Blood samples (8.5mL, fasting preferred) were collected at baseline and at 6 and 12 weeks (visits 5 and 6) after treatment initiation. Serum bone-specific alkaline phosphatase (BSAP) was measured with an immunochemiluminescence assay using the Ostase reagent on an automatic analyzer. Serum amino-terminal propeptide of type 1 collagen (P1NP) was measured with a two-site immunoassay using monoclonal antibodies against purified human P1NP to detect both intact monomeric and trimeric forms, but not fragments. Serum C-terminal cross-linking telopeptide of type 1 collagen (CTX) was measured with a two-site assay using monoclonal antibodies against an eight amino acid sequence from the C-telopeptide of human type 1 collagen. Error bars are standard error of the mean. P values are two-sided.