Romosozumab superior to denosumab for improving spine bone mineral density at 12 months
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SAN DIEGO — Romosozumab is superior to denosumab for increasing bone mineral density in the spine at 12 months among chronic glucocorticoid users with osteoporosis at high fracture risk, according to data presented at ACR Convergence 2023.
“There are few head-to-head randomized clinical trials comparing romosozumab with other anti-osteoporotic agents,” Chi Chiu Mok, MD, of Tuen Mun Hospital in Hong Kong, told attendees.
To compare the efficacy and safety of romosozumab (Evenity, Amgen) with denosumab (Prolia, Amgen), Mok and colleagues recruited a cohort of 70 patients with osteoporosis who were at moderate-to-high risk for osteoporotic fracture, and who had previously been treated with glucocorticoids. The cohort was 93% women with a mean age of age 62.6 ± 9.1 years. The romozosumab regimen was administered subcutaneously at a dose of 210 mg monthly for 12 months, while patients in the denosumab arm received 60 mg subcutaneously every 6 months.
Change in bone mineral density (BMD) from baseline through 12 months served as the primary efficacy endpoint. The researchers also assessed BMD change in the non-dominant hip and femoral neck, change in bone turnover markers, new vertebral fractures and change in BMD at the hip and spine. Safety data also were evaluated. The final analysis included 33 patients in the romosozumab arm and 30 in the denosumab arm who had follow-up data for 12 and 24 weeks.
Baseline data showed that the two groups were comparable in terms of fracture history, glucocorticoid dosing and osteoporosis in the spine, hip or femoral neck. The main difference was that patients in the romozosumab arm had lower hip/femoral neck BMD and serum vitamin D3 levels than those in the denosumab arm.
Month 12 results demonstrated a significant increase in spine BMD in both the romozosumab (+7.3 ± 4.5%; P < .001) and denosumab (+2.3 ± 3.1%; P < .001) arms.
“As you can see, both groups had a significant change in lumbar spine BMD at month 12,” Mok said. “BMD was statistically significantly higher in the romosozumab group than in the denosumab group at every time point.”
In an analysis that adjusted for baseline BMD values, age, sex, osteoporosis risk factors and the cumulative prednisolone doses in 12 months, the researchers reported an inter-group difference in spine BMD at 12 months (P < .001).
Increases in hip BMD were +1.6% ± 3.3% (P = .01) for romozosumab and +1.6% ± 2.6% (P = .003) for denosumab.
“Again, there was significant change in hip BMD at months 12 and 24,” Mok said. “There were also increases in the femoral neck.”
However, adjusted analyses results in both the hip and femoral neck told a slightly different story.
“There was no difference between the two groups after adjusting for covariates,” Mok said.
Denosumab treatment was associated with significant reductions of both serum C-terminal telopeptide (CTX; –34.7 ± 54.8%; P = .002) and propeptide of type 1 procollagen (P1NP; –35.1 ± 43.3%; P < .001), according to the researchers. Conversely, romozosumab yielded a reductions in CTX (–18.1 ± 76.9%; P = .18) but an increase in P1NP (+1.7 ± 70.3%; P = .89).
“For bone formation markers, there was a trend early in the romosozumab group that drops back to the same level as denosumab at month 12,” Mok said. “At the second year, it converges with the denosumab group.”
One new vertebral fracture occurred in the romozosumab group at 12 months.
Meanwhile, further analysis of efficacy findings showed another trend.
“The efficacy if romosozumab is higher in patients who are naïve to any treatment,” Mok said. “But they respond well to both treatments for the first year.”
Self-limiting injection site pain or redness was the most commonly reported adverse event. Patients in the romozosumab arm were more likely to report these events. In addition, two patients in the romozosumab arm and three patients in the denosumab arm reported post-injection musculoskeletal pain. Two denosumab-treated patients reported mild hypocalcemia and hypercalcemia. There were no serious adverse events observed, according to the researchers.
“Romosozumab was superior to denosumab in raising the spine BMD at month 12 in chronic glucocorticoid users with high fracture risk,” Mok concluded.
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Mok CC. Abstract 2429. Presented at: ACR Convergence 2023; Nov. 10-15, 2023; San Diego.
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