Romosozumab Increases Bone Mineral Density in Mid-Stage Trial
Treatment benefits postmenopausal women (January 1)
Positive results have been reported from a phase II trial of romosozumab (Amgen/UCB) in postmenopausal women with low bone mineral density (BMD).
Published in the New England Journal of Medicine, the study demonstrated that, compared with placebo, 12 months of treatment with romosozumab significantly increased BMD at the lumbar spine, total hip, and femoral neck. Significant increases were also observed in the first BMD assessment at 3 months.
Moreover, in exploratory analyses, increases observed at the lumbar spine and hip were significantly greater than those observed with Fosamax (alendronate sodium, Merck) and Forteo (teriparatide, Lilly USA).
Romosozumab is an investigational compound in phase III clinical development for the treatment of osteoporosis in postmenopausal women and is not currently approved by the FDA.
In the phase II trial, each of five romosozumab dose regimens significantly increased BMD compared with pooled placebo groups at the lumbar spine, total hip, and femoral neck regions (all P < 0.001). The largest increases were observed with romosozumab 210 mg administered once monthly, with mean increases compared with baseline of 11.3% at the lumbar spine, 4.1% at the total hip, and 3.7% at the femoral neck.
Source: Amgen; January 1, 2014.