Eli Lilly announces EVista Alendronate Comparison clinical trial

Eli Lilly and Company has announced plans to conduct a large-scale, head-to-head fracture-prevention study of two leading drugs used for the prevention and treatment of osteoporosis in postmenopausal women.

The EVista Alendronate Comparison study (EVA) will compare the drug Evista (raloxifene HCl) with the drug Fosamax (alendronate sodium), in preventing osteoporosis-related fractures.

The EVA study is designed to help women and physicians make informed treatment decisions for protecting bone strength, preventing fractures, and addressing other health conditions that confront women after menopause. EVA is the first head-to-head fracture study comparing approved osteoporosis therapies.

The EVA clinical trial will enroll approximately 3,000 women at about 150 sites in the United States, Puerto Rico and Canada. All participants must be postmenopausal, have osteoporosis, and be 50 to 80 years old.

Half of all participants will receive Evista and half will receive Fosamax. Both drugs are approved for the prevention and treatment of osteoporosis in postmenopausal women. The EVA study will last approximately five years, with early results expected in 2006.

Recruitment for EVA is anticipated to begin in October 2001, with a special emphasis on enrolling African-American, Asian and Hispanic women, who have been largely under-represented in osteoporosis clinical trials.

Postmenopausal women and healthcare professionals who are interested in learning more about the EVA study can call toll free at 877-CTLILLY (877-285-4559).

Source: Eli Lilly