Hagino H, et al. - Ambulatory postmenopausal women and men (≥ 55 years of age) with osteoporosis at high risk of fracture were randomly assigned in a ration of 1:1 to receive either RGB-10 or reference teriparatide 20 μg once daily through subcutaneous self-injection for 52 weeks in order to assess equivalence in the efficiency and contrast safety between RGB-10 and reference teriparatide in individuals with osteoporosis at high risk of fracture for registration in Japan. A total of 250 individuals (125 in each group) were randomized. Among the groups, variations in BMD at the lumbar spine (L1–L4), femoral neck, and total hip and serum procollagen type I amino-terminal propeptide were comparable. Safety profiles, comprising immunogenicity, were similar. Therefore, the therapeutic equivalence of RGB-10 to reference teriparatide was illustrated. Moreover, to that of reference teriparatide, RGB-10 had a similar safety profile.