ROMOSOZUMAB VERSUS DENOSUMAB IN HIGH-RISK PATIENTS WITH GLUCOCORTICOID-INDUCED OSTEOPOROSIS: A PILOT RANDOMIZED CONTROLLED TRIAL
Authors: Ma WH et al.
This study aimed to compare the efficacy and safety of romozosumab (ROMO) and denosumab (DEN) in high-risk patients with glucocorticoid -induced osteoporosis (GIOP). Adult patients (≥18 years) who were receiving daily prednisolone dose of ≥5mg/day for ≥12 months and had moderate/high risk of osteoporotic fracture (history of fragility fracture, DXA T-score ≤-2.5 (age≥40 years) or Z-score ≤-3.0 (age < 40 years) or high risk of 10-year major fracture estimated by FRAX) were included. Participants were given daily calcium/vitamin D and were randomized to receive either ROMO (210mg SC monthly) or DEN (60mg SC every 6 months) for 12 months, followed by DEN (60mg every 6 months) for 12 more months in both arms.
70 patients were recruited and 63(90%) completed the study (mean age 62.6; 96% women). At month 12, a significant increase in spine BMD was observed in both the ROMO (+7.3±4.5%; p< 0.001) and DEN (+2.3±3.1%; p< 0.001) groups of patients. The corresponding increase in hip BMD were +1.6%±3.3% (p=0.01) in the ROMO group and +1.6%±2.6% (p=0.003) in the DEN group. No significant inter-group difference in hip BMD was observed. Only one new vertebral fracture developed in the ROMO group at 12 months. No serious AEs were reported.
Romosozumab was superior to denosumab in raising the spine but not the hip BMD at month 12 in chronic GC users with high fracture risk. Both drugs were well tolerated. Romosozumab may offer a new treatment option for GIOP in high-risk patients, but prospective controlled studies to evaluate the efficacy with the primary endpoint of fracture prevention need to be done.