TRIAL COMPARES OSTEOPOROSIS TREATMENTS BONIVA, FOSAMAX

Roche and GlaxoSmithKline (GSK) are raising the stakes in the osteoporosis drug market, announcing that they will launch a clinical trial pitting their new monthly osteoporosis treatment Boniva against Pfizer's Fosamax, the current market leader.

The MOTION trial (Monthly Oral Therapy with Ibandronate for Osteoporosis INtervention) is a one-year noninferiority study that will compare the efficacy and safety of once-monthly oral Boniva (ibandronate sodium) and weekly oral Fosamax (alendronate sodium).

The randomized, double-blind, double-dummy study will enroll approximately 1,900 women with postmenopausal osteoporosis. The primary endpoints are percent change from baseline in lumbar spine and total hip bone mineral density at one year.

Roche and GSK received FDA approval for once-monthly Boniva in late March, and launched the product in April. The development partners are hoping the product's more convenient dosing regimen will help it gain inroads against Fosamax, which must be taken every week.