OBJECTIVES:  Recombinant human parathyroid hormone (rhPTH) was recently approved in the US as an adjunct to oral calcium and active vitamin D for control of hypocalcemia in adults with hypoparathyroidism who cannot be well-controlled on calcium and vitamin D supplements alone. In a Phase III trial (NCT00732615; EudraCT2008-005063-34), 55% and 2.5% of subjects randomized to receive rhPTH (n=84) and placebo (n=40), respectively, attained the composite primary endpoint -- ≥50% reduction in oral calcium intake, ≥50% reduction in active vitamin D dose, and maintenance of albumin-corrected serum calcium level -- over the 24-week follow-up period (p<0.001) (Mannstadt et al., Lancet Diabetes Endocrinol