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news.Chugai Pharmaceutical has released the results of a Phase III study of an active vitamin D3 derivative (eldecalcitol), which is developed in Japan for the indication of osteoporosis.
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Chugai said that the Phase III study was a randomised, double-blind, parallel-group, comparative study to compare the 3-year incidence of bone fractures and the safety of eldecalcitol with those of alfacalcidol in 1,054 patients with osteoporosis.
Reportedly, results from the Phase III study showed that the patients who received Eldecalcitol had a lower incidence of new vertebral fractures and the forearm bone fractures compared to those who received alfacalcidol.
Additionally, it was observed that the overall safety profile of eldecalcitol was similar to that of alfacalcidol.
Chugai has filed a new drug application for eldecalcitol in October 2009.