Eli Lilly has reported new data showing that treatment with FORTEO for 24 months was associated with significantly fewer vertebral and clinical fractures (a composite of painful vertebral and non-vertebral fractures) compared with risedronate, a widely used oral bisphosphonate, in postmenopausal women with severe osteoporosis in the VERO clinical trial.
The company said that results from the study’s primary endpoint showed that at 24 months, fewer patients taking FORTEO had new vertebral fractures as compared to patients taking risedronate (5.4% vs. 12.0%, p < 0.0001).
The two year randomized, double-blind, double-dummy clinical trial compared subcutaneous daily teriparatide (20 μg) with oral weekly risedronate (35 mg) in 1,360 women with at least two moderate or one severe vertebral fracture and low bone mass.
“The VERO study data reinforces the efficacy of FORTEO® in reducing fractures and can help physicians make informed prescribing decisions,” said David L. Kendler, Professor of Endocrinology in the University of British Columbia, Vancouver and first author of the article.
This is the first trial in osteoporosis research that has shown a significant fracture reduction outcome as a primary endpoint in a head-to-head, active-drug comparative study.