Osteoporosis Treatment Program: Phase lll Results
Positive safety and efficacy results were reported in Tarsa’s global randomized Phase III ORACAL trial evaluating the safety and efficacy of TBRIA™ in postmenopausal women with osteoporosis . TBRIA achieved all of the efficacy endpoints in the trial, demonstrating superiority to both placebo and nasal calcitonin spray in increasing bone mineral density (BMD) at the lumbar spine after 48 weeks in postmenopausal women with osteoporosis. In the trial, the safety profile of TBRIA did not substantially differ from nasal calcitonin or placebo. The majority of adverse events were mild or moderate, and TBRIA was significantly less immunogenic than nasal calcitonin spray.
Tarsa Therapeutics’ TBRIA™ recombinant oral salmon calcitonin achieved its safety and efficacy endpoints in the Phase III ORACAL trial.
 A Phase 3 Trial of the Efficacy and Safety of Oral Recombinant Calcitonin: The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) Trial, N Binkley, M Bolognese, A Sidorowicz-Bialynicka , T Vally, R Trout, C Miller, C E Buben, J P Gilligan, and DS Krause, Journal of Bone and Mineral Research, DOI: 10.1002/jbmr.1602 (p. 1821-1829)