NCT03005678已完成4 期
Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- bone mineral density at lumbar spine
研究概览
简要总结
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis
详细描述
Study design: an open-label randomized controlled trial Duration of study: 12 months
Treatment arms:
- Denosumab: a total of 2 doses in a period of 12 months
- Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)
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
- •Adults (women or men) >18 years of age
- •Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
- •Informed consent from patients.
- •Willing to comply with all study procedures
排除标准
- •Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
- •Premenopausal women who plan for pregnancy within 18 months of study entry.
- •Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- •Patients with unexplained hypocalcemia.
- •Patients with serum creatinine level of >=200umol/L.
研究组 & 干预措施
Denosumab
Active Comparator
denosumab subcutaneous 60mg every 6 months
干预措施: Denosumab (Drug)
Alendronate
Placebo Comparator
alendronate 70mg orally every week
干预措施: Alendronate (Drug)
结局指标
主要结局
bone mineral density at lumbar spine
时间窗: month 12
BMD lumbar spine
次要结局
- bone mineral density at the hip(month 12)
- bone turnover markers(month 12)
- adverse events(month 12)
研究者
Chi Chiu Mok
Principal investigator
Tuen Mun Hospital
研究点 (1)
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