OP0246 romosozumab versus denosumab in high-risk patients with glucocorticoid-induced osteoporosis: a pilot randomized controlled trial
Abstract
To compare the efficacy and safety of romozosumab (ROMO) and denosumab (DEN) in high-risk patients with glucocorticoid (GC)-induced osteoporosis (GIOP).Design: A pilot open randomized controlled trial.Method: Adult patients (≥18 years) who were receiving daily prednisolone dose of ≥5mg/day for ≥12 months and had moderate/high risk of osteoporotic fracture (a history of fragility fracture, DEXA T score ≤-2.5 [age ≥40 years] or Z scores ≤-3.0 [age <40 years] or high risk of 10-year major fracture estimated by FRAX) were included. Participants were given daily calcium and vitamin D and existing bisphosphonates were discontinued. Subjects were randomized by blocks 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. The primary efficacy end point was the change in bone mineral density (BMD) at the lumbar spine from baseline to month 12. Secondary end points included BMD change at the non-dominant hip and femoral neck at month 12, change in bone turnover markers, new vertebral fractures, change in BMD at the hip and spine at month 24 and adverse events.Of 70 patients recruited, 63(90%) completed the study (age 62.6±9.1 years; 96% women; 35 each assigned to ROMO or DEN). Underlying medical diseases were systemic lupus erythematosus (51%), rheumatoid arthritis (29%), inflammatory myopathies (9%) and others. The mean prednisolone dose at entry was 6.6±3.5mg/day. Osteoporosis at…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 70 participants or records.
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