A study published as part of the American College of Rheumatology Annual Meeting compared denosumab versus alendronate for patients with osteoporosis receiving long-term glucocorticoids and found that denosumab better increased spinal bone mineral density (BMD) after 12 months of treatment.
The study included 139 adult patients (mean age, 50 years) receiving long-term prednisolone 2.5 mg per day for one year. Patients were randomized to receive denosumab 60 mg subcutaneously every six months (n=69) or alendronate 70 mg per week (n=70). Patients also received calcium 3,000 mg per day and vitamin D3 1,000 IU per day. Most patients (81%) had systemic lupus erythematosus.
More than half of patients (n=73; 53%) had osteoporosis of the hip, femoral neck, or lumbar spine. Preexisting fragility or vertebral fracture was present in 19 patients (14%), and 18 patients (13%) had a family history of fractures.
At 12 months post-treatment, patients treated with denosumab had a significant gain in BMD at the lumbar spine (+3.5% vs. +2.5%; P<0.001) and hip (+0.9 vs. 2.7%; P=0.01) compared with those in the alendronate group. Spinal BMD at 12 months was significantly higher in the denosumab group after adjusting for BMD values at baseline, age, sex, and other osteoporosis risk factors, including smoking, drinking, cumulative steroid doses in one year, body mass index, menopausal status, and personal history of fracture (P=0.045). Differences in hip and femoral neck BMD were not significantly different between the two treatment groups after adjusting for the same confounding factors.
No new symptomatic fractures occurred in any participants. Adverse events (AEs) were similar in frequency between the two groups. Minor upper gastrointestinal symptoms and non-specific dizziness were numerically more common in the alendronate group, while arthralgia, minor infections, and new hypertension was more commonly reported in the denosumab group. Three patients in the alendronate group and two in the denosumab arm withdrew from the study due to non-compliance; no withdrawals were related to AEs.