Results of the Phase III androgen deprivation therapy (ADT) clinical trial demonstrate that toremifene citrate 80mg compared to placebo built bone and prevented fractures, reduced hot flashes, and treated other estrogen related side effects of ADT. Studies have shown that men on ADT are three times more likely to experience a fracture than postmenopausal women, and that when they develop a fracture, their median survival rate decreases by more than three years.
In a modified intent to treat analysis, which included all patients with at least one evaluable study radiograph and a minimum of one dose of study drug or placebo, patients receiving toremifene citrate 80mg had approximately a 53% reduction in new morphometric vertebral fractures compared to placebo (p=0.03).
Matthew Smith, lead investigator of the Phase III ADT clinical trial, said: “The results of the Phase III ADT clinical trial are exciting, as they demonstrate that toremifene citrate 80mg prevents fractures and treats other side effects of ADT.”