Denosumab superior to alendronate in raising spinal BMD in long-term glucocorticoid users
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Among patients using long-term glucocorticoids, denosumab is superior to alendronate in increasing bone mineral density in the spine after 1 year, according to a speaker at ACR Convergence 2020.
“Glucocorticoids are the mainstay of treatment of autoimmune inflammatory diseases, but it is also the leading cause of secondary osteoporosis,” Chi Chiu Mok, MD, of Tuen Mun Hospital, in Hong Kong, told attendees at the virtual meeting. “The long-term use of steroids increases the risk of fracture at a much higher bone mineral density then postmenopausal osteoporosis, indicating an additional negative effect of steroids on bone quality. The first-line treatment of glucocorticoid-induced osteoporosis is oral bisphosphonates. However, the drawback of these drugs is the low adherence rates.”
“Denosumab is a humanized monoclonal antibody against RANK ligand, which is administered by subcutaneous injection,” he added. “Several head-to-head random clinical trials in postmenopausal women demonstrated that denosumab was more effective than oral bisphosphonates in suppressing bone turnover and raising spinal bone mineral density after 12 months’ treatment. However, there is a paucity of data regarding the comparative efficacy of denosumab and the oral bisphosphonates in long-term steroid users.”
To analyze the efficacy of denosumab (Prolia, Amgen) compared with alendronate, in raising spinal bone mineral density among patients using glucocorticoids long-term, Mok and colleagues recruited 139 adults who had been receiving 2.5 mg of daily prednisone for 1 year. Patients who previously used denosumab or teriparatide, those who planned to become pregnant, and those with metabolic bone disease or unexplained hypocalcemia or renal insufficiency, were excluded. Included participants were randomly selected to receive either 60 mg of subcutaneous denosumab every 6 months or 70 mg of alendronate every week.
Among the participants, 81% were diagnosed with systemic lupus erythematosus, 9.4% had rheumatoid arthritis and 5% had myositis. In all, 69 participants were treated with denosumab while 70 received alendronate. Patients also received 3,000 mg of calcium and 1000 IU of vitamin D3 daily. Bone mineral density was assessed in the femoral neck, total hip and lumbar spine at months 0, 6 and 12. The researchers also assayed markers of bone turnover — serum P1NP and CTX — at the same time periods. The primary outcome was the difference of bone mineral density change in the lumbar spine at month 12 between the two treatment groups.
According to the researchers, participants treated with denosumab demonstrated a significant gain in bone mineral density at the lumbar spine — 3.5% ±2.5% (P < .001) — and the hip — 0.9% ±2.8% (P = .01) — at 1 year. Meanwhile, the corresponding change in the alendronate group was an increase of 2.5% ±2.9% (P < .001) and an increase of 1.6% ±2.7% (P < .001), respectively.
In addition, spinal bone mineral density at 1 year was significantly higher in the denosumab group compared with those receiving alendronate after adjusting for baseline figures, age, sex and other osteoporosis risk factors such as smoking, drinking, cumulative steroid doses in one year, BMI, menopausal status and personal history of fracture (P = .045).
The differences in hip and femoral neck bone mineral density were not significantly different between the two groups after adjusting for the same confounding factors. No new symptomatic fractures occurred in any participants at 1 year. Adverse events were similar in frequency between the two groups. In addition, major infections were uncommon — 0.06 per patient per year — and similar in the two groups, according to the researchers.
Minor upper gastrointestinal symptoms and non-specific dizziness were numerically more common in the alendronate group. Meanwhile, arthralgia, minor infections — upper respiratory tract, for example — and new hypertension was more commonly reported in those treated with denosumab. Three patients who received alendronate, and two from the denosumab group, withdrew from the study due to non-compliance. None withdrew because of adverse events.
“In Chinese patients receiving long-term glucocorticoids, denosumab is superior to alendronate in raising spinal bone mineral density and suppressing bone turnover markers after 12 months of treatment,” Mok said. “Both denosumab and alendronate were generally well-tolerated.”
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Mok CC. Abstract 1442. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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