Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users
Status:
Recruiting
Trial end date:
2024-04-15
Target enrollment:
Participant gender:
Summary
Glucocorticoid (GC) is the main stay of treatment of many rheumatic diseases but is also an
important cause of secondary osteoporosis. The long-term use of GCs increases the risk of
fragility fracture at a much higher bone mineral density (BMD) than postmenopausal
osteoporosis, indicating an additional deleterious effect of GC on bone quality. An increased
relative risk of vertebral and hip fractures is demonstrated in chronic GC users, with
fracture risk proportional to the daily dose of GC. Other studies have also confirmed that
intermittent use of high-dose GC and the cumulative GC dose was associated with an augmented
risk of osteoporotic fracture.
Romosozumab (ROMO) is a humanized monoclonal antibody against sclerostin. The landmark RCT
has demonstrated efficacy of ROMO (210mg subcutaneously monthly) over placebo in reducing
vertebral fractures by 73% at 12 months in 7180 postmenopausal women with osteoporosis of the
hip at entry. Another RCT has demonstrated efficacy of ROMO in reducing vertebral and hip
fractures in 4093 post-menopausal women at month 24.
There are no data regarding the efficacy of ROMO in GC-induced osteoporosis. Comparative
study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet
available in the literature. This prompts the current pilot study to compare the efficacy of
ROMO with denosumab in high-risk patients receiving long-term GCs.