Surgery News

Arzoxifene phase 3 study results reported by Lilly

February 06, 2016

Lilly is in the process of contacting the clinical investigators conducting ongoing arzoxifene clinical trials. Subject to protocol requirements, the trials will be discontinued, and the patients currently enrolled will be encouraged to speak with a healthcare professional regarding other therapeutic options. Patients involved in arzoxifene clinical studies who have questions should contact their study investigator.

About GJAD "GENERATIONS" Study

The GJAD "GENERATIONS" Study is a Phase III, double-blind, randomized, placebo-controlled, five-year study of 9,354 postmenopausal women, throughout 22 countries, 60-85 years of age, with either documented osteoporosis or low bone mass. Participants were randomly assigned to arzoxifene 20 mg/day or placebo, and also received elemental calcium 500 mg/day and 400-600 IU/day vitamin D.

Primary endpoints were vertebral fractures in the osteoporosis population and invasive breast cancer in the overall study population. Secondary efficacy endpoints included non-vertebral fractures, clinical vertebral fractures, cardiovascular events (coronary events and stroke), and cognitive function. Key safety endpoints included all-cause mortality, gynecological-related events (including endometrial carcinoma and hyperplasia), and venous thromboembolic events (VTEs).

The primary vertebral fracture endpoint was based on three-year data, consistent with FDA guidance on development of osteoporosis products, whereas the primary invasive breast cancer analysis, secondary outcome analyses and safety analyses were based on four-year data.

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