BioCentury
ARTICLE | Clinical News

Natpara: Additional Phase III data

November 5, 2012 8:00 AM UTC

Additional data from the double-blind, dose-escalation, international Phase III REPLACE trial in 134 patients showed that once-daily Natpara produced significant increases in bone turnover markers at week 24 vs. baseline, while placebo produced no significant changes. Specifically, Natpara led to significant increases at week 24 vs. baseline of 21 µg/L in bone alkaline phosphatase, 799 µg/L in C-terminal telopeptide (CTX), 299 µg/L in procollagen type I N-propeptide (PINP) and 26 µg/L in osteocalcin (p<0.001 for all). Placebo led to non-significant increases in each endpoint at week 24 vs. baseline of 1, 43, 4 and 0 µg/L, respectively (p<0.001 for all). Natpara also significantly reduced Z-scores, a measure of bone mineral density (BMD), in the hip at week 24 from baseline vs. placebo (p<0.001). Patients initially received 50 µg Natpara, which was titrated as needed up to 75 µg, and then to 100 µg over a 6-8 week period. Data were presented at the American Society for Bone and Mineral Research meeting in Minneapolis. ...