Spine bone mineral density gains greater with denosumab vs alendronate

Denosumab produces superior increases in spine bone mineral density (BMD) compared with alendronate in chronic steroid users, according to a study.

In total, 139 individuals (mean age, 50.0 years; 96 percent female) receiving long-term prednisolone (≥2.5 mg/day for ≥1 year) were randomized to either subcutaneous denosumab (60 mg/6 months; n=69) or oral alendronate (70 mg/week; n=70).

At baseline, 73 (53 percent) participants were osteoporotic and 82 (59 percent) patients were naïve to bisphosphonates. BMD (lumbar spine, femoral neck, and hip) and bone markers (serum P1NP and CTX) were measured at month 0, 6, and 12.

Baseline clinical characteristics and BMD values were comparable in the two treatment arms. At month 12, denosumab resulted in significant gains in mean BMD at the lumbar spine (3.5 percent; p<0.001), hip (0.9 percent; p=0.01), and femoral neck (1.04 percent; p=0.047). The corresponding changes seen with alendronate were 2.5 percent (p<0.001), 1.6 percent (p<0.001), and 1.5 percent (p=0.002).

BMD at the spine, but not the hip or femoral neck, at month 12 was significantly higher in the denosumab than alendronate group in an analysis controlled for baseline BMD values, age, sex, osteoporosis risk factors, and the cumulative prednisolone doses received in 1 year.

The magnitude of decline in serum P1NP and CTX was greater with denosumab.

There was no significant between-group difference observed in the frequency of adverse events (AEs), including infections. Seven patients discontinued treatment, the reasons for which were not related to AEs.