Chugai Pharmaceutical Company Limited Beijing Representative Office

Methods: The pharmacokinetics of a single oral dose of ED-71 (0.5 μg and 0.75 μg) on an empty stomach was studied in healthy adult males using a 2×2 crossover design (unblinded), and its safety was also evaluated.

The efficacy and safety of ED-71 were studied in patients with primary osteoporosis through a randomized, double-blind, double-dummy, parallel controlled trial with alfacalcidol as the control drug. Lumbar spine bone density was used as the main evaluation index to verify the superiority of ED-71 over alfacalcidol.