Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis: a 2-year Extension Study of a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- change in BMD at the lumbar spine
研究概览
简要总结
The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.
详细描述
The investigators conducted a pilot open-label 24-month randomized controlled trial (RCT) comparing the efficacy of romosozumab (ROMO) with denosumab (DEN) in moderate/high risk adult patients using long-term GCs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). All patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy X-ray absorptiometry (DXA) T score ≤-2.5 [age ≥40 years] or Z scores ≤-3.0 [age <40 years] at spine, hip or femoral neck; or (3) high risk of 10-year FRAX-estimated major fracture).
Of the 70 patients enrolled, 63 completed the study. At month 12, the spine bone mineral density (BMD) increased significantly in both the ROMO and DEN groups. The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients (p<0.001). Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups, the BMD gain was not significantly different between the groups. At month 24, the spine BMD continued to increase in both the ROMO and DEN groups, and the BMD gain remained significantly greater in ROMO-treated patients.
As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP, the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 24 in our original RCT
- •Those who are willing to have a repeat DXA assessment at the end of 4 years.
排除标准
- •patients who refuse to be maintained on denosumab after month 24;
- •patients who are maintained on other anti-osteoporotic drugs after month 24; and
- •patients in whom prednisolone is planned to be tapered or discontinued after month 24.
研究组 & 干预措施
Romosozumab/denosumab
Romosozumab for 12 months, then denosumab for 36 months
干预措施: Romosozumab (Drug)
Romosozumab/denosumab
Romosozumab for 12 months, then denosumab for 36 months
干预措施: Denosumab (Drug)
Denosumab/denosumab
Densoumab for 48 months
干预措施: Denosumab (Drug)
结局指标
主要结局
change in BMD at the lumbar spine
时间窗: 24 more months after RCT completion
spine BMD
次要结局
- change in BMD at non-dominant hip and femoral neck(24 more months after RCT completion)
研究者
Chi Chiu Mok
Consultant and honorary professor
Tuen Mun Hospital