Amgen has announced that twice-yearly subcutaneous injections of 60 mg denosumab increased bone mineral density (BMD) of the lumbar spine by 7.4% and of the total hip by 5.1% compared with 6.2% and 3.4%, respectively, for alendronate (Fosamax®) 70 mg/week over a 24-month period.
Therapy with denosumab—an inhibitor of RANK Ligand, the primary signal to promote bone removal—did not produce neutralizing antibodies throughout the 2 years.
Findings from the ongoing multicenter, randomized, phase II dose-ranging trial (6 mg, 14 mg, or 30 mg denosumab every 3 months; or 14 mg, 60 mg, 100 mg, or 210 mg every 6 months) were presented at the 69th Annual Meeting of the American College of Rheumatology in San Diego, California.
The results emerged from an analysis of 337 healthy postmenopausal women with low BMD who completed 2 years of the study. Denosumab is currently being evaluated in a broad range of bone-loss conditions, including osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and rheumatoid arthritis.
—A. Techman