Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Roche and GlaxoSmithKline have jointly commenced a large-scale clinical trial that, for the first time, directly compares Boniva, their new monthly osteoporosis treatment, against the market leader, Merck's Fosamax.
Subscribe to our email newsletter
The one-year trial is expected to include 1,900 women with postmenopausal osteoporosis. The trial, known as Motion, is a non-inferiority study that will compare the efficacy and safety of once-monthly oral Boniva and weekly oral Fosamax.
“This is a very important study because these two treatment regimens have never before been directly compared,” said Dr Felicia Cosman, medical director of the Clinical Research Center, Helen Hayes Hospital, New York. “This trial will measure each treatment’s ability to increase bone mineral density, an accepted surrogate for determining the risk of fracture, the most relevant consequence of postmenopausal osteoporosis.”
The primary endpoints of the Motion trial are percent change from baseline in lumbar spine and total hip bone mineral density (BMD) at one year. Secondary endpoints include percent change in hip trochanter BMD at one year and biochemical markers of bone turnover in a subset of patients at day seven and months three, six and 12. Clinical vertebral and non-vertebral fractures will also be assessed, and their respective rates compared. Adverse events will be monitored throughout the study.