Natpara: Phase III data

The double-blind, U.S. Phase III RELAY trial in 46 patients showed that 18% of patients receiving 25 µg Natpara and 25% of patients receiving 50 µg Natpara achieved the primary endpoint of a reduction in daily oral calcium supplementation to <=500 mg and daily supplemental calcitriol to <=25 µg while maintaining albumin-corrected total serum calcium >=7.5 mg/dL at week 8. Additionally, 9% of patients receiving 25 µg Natpara and 29% of patients receiving 50 µg Natpara met the secondary endpoint of a >=50% reduction from baseline in both oral calcium supplementation and supplemental calcitriol as well as a normalized or maintained total serum calcium concentration from baseline to week 8. Both doses of Natpara led to increases from baseline at week 8 in bone turnover markers C-terminal telopeptide (CTX), procollagen type I N-propeptide (PINP) and osteocalcin vs. placebo. Both doses were well tolerated with paresthesia, nausea, muscle spasms, fatigue and headache reported as the most common adverse events. Patients received once-daily 25 or 50 µg Natpara for 8 weeks. Data were presented at the American Society for Bone and Mineral Research meeting in Minneapolis. ...