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November 14, 2011
NPS Pharmaceuticals reported results from a phase III trial of NPSP-558 for the treatment of hypoparathyroidism. This double-blind, placebo-controlled trial, REPLACE, enrolled 135 subjects. Following randomization, subjects underwent staged reductions in calcium and vitamin D supplementation, while maintaining stabilized serum calcium. If needed, step-wise up-titration of NPSP558 or placebo to a dose of 75 g and, if necessary, up to 100 g over a six to eight week period was performed. Subjects continued on their final dose through week 24. The primary efficacy was to demonstrate by week 24 at least a 50 percent reduction from baseline of oral calcium supplementation and active vitamin D metabolite/analog therapy and a total serum calcium concentration that was normalized or maintained compared to baseline. In an intent-to-treat analysis, 53% of NPSP558-treated subjects achieved the primary endpoint versus 2% of placebo-treated subjects (p<0.0001). At week 24, 43% of subjects treated with NPSP558 were able to achieve independence from active vitamin D therapy and a calcium supplementation dose of 500 mg/day or less, as compared to 5% of subjects treated with placebo (p<0.0001).
December 1, 2003
Amgen reported positive results from a phase III trial investigating cinacalcet, a calcium-sensing receptor modulator for the treatment of hyperparathyroidism (HPT). Results showed a 13 to 17 % reduction in calcium-phosphorus product, a 6-8% reduction in calcium and a 7-10% reduction in phosphorus compared to baseline levels after standard therapy and placebo. Data showed that 36 to 48% of subjects taking cinacalcet achieved the primary endpoint of parathyroid hormone (PTH) less than or equal to 250 pg/mL compared to 4 to 7% of subjects on standard therapy. The three double-blind, randomized, placebo-controlled studies enrolled more than 1,100 subjects on hemodialysis and peritoneal dialysis with uncontrolled secondary HPT. The Studies were conducted in Australia, Canada, Europe and the U.S. Results were reported at the American Society of Nephrology (ASN) symposium in San Diego.