Home > Rheumatology > ACR 2023 > Osteoporosis > Romosozumab tops denosumab in glucocorticoid users with high fracture risk

Romosozumab tops denosumab in glucocorticoid users with high fracture risk

Presented by
Dr Chi Chiu Mok, Tuen Mun Hospital, Hong Kong, China
ACR 2023
In postmenopausal women treated with glucocorticoids who have a moderate-to-high risk of osteoporotic fractures, the efficacy and safety of romosozumab and denosumab were compared. After 1 year of follow-up, romosozumab was superior to denosumab in raising the bone mineral density (BMD) of the spine, which was the study's primary endpoint.

Romosozumab is a humanised monoclonal antibody sclerostin inhibitor indicated for the treatment of severe osteoporosis in postmenopausal women with a high fracture risk. Romosozumab and denosumab had never been compared in a head-to-head study. The group of Dr Chi Chiu Mok (Tuen Mun Hospital, Hong Kong, China) set up a non-sponsored pilot randomised trial, for which they recruited 70 postmenopausal participants who had received prednisolone for ≥1 year (at a dose of at least 5 mg/day) and who were at moderate or high risk of osteoporotic fracture [1]. Of the participants, 35 were assigned to romosozumab (210 mg, subcutaneously, monthly) and 35 to denosumab (60 mg, subcutaneously, every 6 months) for 1 year, followed by open-label denosumab for another year. The primary efficacy endpoint was BMD change of the lumbar spine after 1 year.

The mean age of participants was 62.6 years, and 96% were women. The mean dose of prednisolone at baseline was 6.6±3.5 mg/day. About half of the patients (48.6%) had osteoporosis at the spine, hip, or femoral neck, 50% had had 1 or more fragility fractures, while nearly half (47%) were on oral bisphosphonates before the start of the study. At baseline, the romosozumab group had lower hip or femoral neck BMD and serum vitamin D3 levels than the denosumab group.

Spine BMD increased significantly in both groups at 1 year. However, the increase in the experimental group was more notable (7.3%; P<0.001) than in the denosumab group (2.3%; P<0.001). At 2 years, the increase was 9.67% and 2.96%, respectively. The difference in spine BMD remained statistically significant after adjusting for baseline BMD, age, sex, osteoporosis risk factors, and cumulative prednisolone doses (P<0.001). Surprisingly, there was no difference in hip BMD in years 1 and 2. Hip BMD increased by 1.6% in both the romosozumab and denosumab groups at 1 year (P=0.01 and P=0.003, respectively). No significant increase in femoral neck BMD in any of the 2 groups was observed. At 1 year, 3 patients had a new or worsened vertebral fracture in the experimental group. At 2 years, 4 patients in the experimental group and 1 in the control group had a new or worsened vertebral fracture.

The most common adverse event was self-limiting pain or redness at the injection site, which was significantly more common in the romosozumab arm, where the administration took place on a monthly basis. No serious adverse events were reported.

  1. Mok CC, et al. Romosozumab versus denosumab in high-risk patients treated with glucocorticoids: interim 12-month results from a pilot randomized controlled trial. 2429, ACR Convergence 2023, 10–15 November, San Diego, USA.

Medical writing support was provided by Michiel Tent.
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