Romosozumab associated with bone density increase

Results of a Phase II study suggest that romosozumab significantly increases bone mineral density (BMD) in the lumbar spine, total hip, and femoral neck. Exploratory analyses showed the BMD increases in the lumbar spine and hip were significantly higher with romosozumab than alendronate sodium and teriparatide in postmenopausal women with low BMD.

Researchers from the Oregon Osteoporosis Center evaluated the efficacy of romosozumab for a 12-month period in 419 women aged 55 to 85 years of age who had low BMD (T score -2.0 or less at the lumbar spine, total hip, or femoral neck and -3.5 or more at each of the 3 sites). Participants were randomly assigned to monthly romosozumab (a dose of 70 mg, 140 mg, or 210 mg) or romosozumab every 3 months (a dose of 140 mg or 210 mg) administered subcutaneously; subcutaneous placebo; or an open-label active comparator – oral alendronate (70 mg) administered weekly or subcutaneous teriparatide (20 μg) administered daily.

The investigators found that all dosage levels of romosozumab were associated with significant BMD increases at the lumbar spine, an increase of 11.3% with the 210 mg monthly dose. In comparison, teriparatide resulted in an increase of 7.1% and alendronate in an increase of 4.1%. BMD decreased 0.1% in the comparator group. Romosozumab was also associated with significant increases in BMD at the total hip and femoral neck, transitory increases in bone-formation markers, and sustained descreases in a bone-resorption marker. Adverse effects were mild across all dosage groups, with the most common being mild, generally nonrecurring injection-site reactions.

The scientists concluded that romosozumab was associated with increased BMD and bone formation in postmenopausal women.

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