Efficacy of romosozumab followed by denosumab in glucocorticoid users; a randomized clinical trial.

UNLABELLED: The efficacy of romosozumab (ROMO) in treating glucocorticoid-induced osteoporosis remains unclear. This randomized clinical trial demonstrated that in patients initiating glucocorticoid therapy, a treatment regimen of 12 months of ROMO followed by 24 months of denosumab (DMAb) was effective compared to either 36 months of DMAb or bisphosphonate monotherapy.

PURPOSE: The efficacy of romosozumab (ROMO), an antibody against sclerostin-an inhibitor of Wnt signaling-in the treatment of glucocorticoid-induced osteoporosis remains uncertain, particularly regarding the sequential use of ROMO and denosumab (DMAb). This study aimed to compare the long-term efficacy of 12 months of ROMO followed by 24 months of DMAb (ROMO-DMAb) to 36 months of DMAb or bisphosphonates (BP) alone.

METHODS

Patients with rheumatic diseases who had not previously received osteoporosis drugs and were newly treated with prednisolone ≥ 15 mg/day were randomly assigned to receive ROMO (ROMO-DMAb group), DMAb, or risedronate. Over a 36-month period, we measured bone mineral density (BMD) at the lumbar spine, femoral neck, and total hip every 6 months.

RESULTS

Thirty-nine patients (median [interquartile ranges] age 72.0 [67.3 - 78.8] years; 69.2% women; prednisolone dose 20.0 [15.0 - 50.0] mg/day) were enrolled. The median percent change in lumbar spine BMD from baseline at 36 months was greatest in the ROMO-DMAb group (ROMO-DMAb; 11.3 [6.8 - 13.8] %, DMAb; 9.4 [4.7 - 13.5] %, BP; 2.1 [-1.3 - 6.8] %). The changes in the femoral neck and total hip were similar between the ROMO-DMAb and DMAb groups, and the increases were much smaller than that in the lumbar spine. Serum levels of total type I procollagen-N-propeptide and tartrate-resistant acid phosphatase-5b decreased in all groups from month 3.

CONCLUSION

Sequential treatment with ROMO followed by DMAb increased lumbar spine BMD more than DMAb or BP alone up to 36 months, demonstrating the efficacy of this treatment strategy.