Romosozumab: the new option for glucocorticoid-induced osteoporosis with high fracture risk?

When comparing the increase in bone mineral density (BMD) after 1 year of romosozumab with BMD after 12 months of denosumab, the adjusted rates were significantly higher in the romosozumab arm. The tolerance of both drugs was overall good.

Romosozumab is a humanised monoclonal antibody against sclerostin, with demonstrated efficacy in postmenopausal women with osteoporosis. However, until now, no data regarding its efficacy in glucocorticoid-induced osteoporosis has been available.

The 24-month, open, controlled trial (NCT04091243) included 70 adult patients receiving at least 5 mg of daily prednisolone for ≥1 year, who were randomised to either romosozumab (210 mg monthly) or denosumab (60 mg every 6 months) for 12 months, followed by 1 year of denosumab for both groups [1]. All participants had a moderate or high risk of osteoporotic fractures. The primary outcome was defined as the change in BMD of the lumbar spine at 12 months. The study protocol included suspending previous bisphosphonates therapy while continuing calcium and vitamin D treatment.

The study population had a mean age of 62.9 years, and 96% were women. The most frequent primary diagnoses were systemic lupus erythematosus (51%) and rheumatoid arthritis (29%). About half of the study cohort had a history of fragility fractures. “The mean prednisolone dose at entry was 6.6 mg/day, and bisphosphonates were used in around half of the patients at the time of recruitment,” Dr Chi Chiu Mok (Tuen Muk Hospital, China) elaborated. At baseline, significant differences between the 2 study groups were not found.

The main results revealed significant increases of BMD in the lumbar spine at month 12: +7.3% in the romosozumab group (P<0.001) and +2.3% in the denosumab group (P<0.001), compared with baseline. Adjusting the results for baseline BMD, age, sex, and other osteoporosis risk factors, a significant difference between the treatment arms was found (P<0.001). The changes from baseline in hip and femoral neck BMD were also significant at 12 months; however, no inter-group difference was found. Concerning markers of bone turnover, both N-terminal propeptide of type 1 procollagen (P1NP) and carboxy-terminal collagen crosslinks (CTX) significantly dropped in the denosumab arm (P<0.001 and P=0.002), whereas a decrease in CTX and a slight rise in P1NP on romosozumab group were not significant (P=0.18 and P=0.89).

The most frequent adverse event was injection-site pain, which was present in 8 cases in the romosozumab group, but not in the denosumab arm. Dr Mok hypothesised that this difference was caused by the higher frequency of the romosozumab injections as they were given monthly, while denosumab injections occurred only twice in 1 year.

“Romosozumab may thus offer a new treatment option for glucocorticoid-induced osteoporosis in high-risk patients,” Dr Mok concluded.

1. Mok CC. Romosozumab versus denosumab in high-risk patients with glucocorticoid-induced osteoporosis: a pilot randomised controlled trial. OP0246, EULAR 2023, 31 May–3 June, Milan, Italy.

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Posted on 31 July 202317 May 2024