NCT00100620已完成3 期
Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 12
- 主要终点
- Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
研究概览
简要总结
The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long duration treatment with corticosteroids (started or ongoing)
排除标准
- •History of osteogenesis imperfecta, multiple myeloma or Paget's disease
- •History of Hyperparathyroidism, hyperthyroidism
- •History of Osteomalacia
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
次要结局
- Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
- Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline
- Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12
- Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy
研究者
研究点 (12)
Loading locations...
相似试验
已完成
4 期
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric SurgeryBariatric Surgery CandidateNCT03424239Massachusetts General Hospital6
已完成
不适用
To find out effect of Injection Zoledronic acid for treatment of bone weakening condition in patients having long term liver problems/damage.CTRI/2020/03/024247Pt BD Sharma PGIMS Rohtak49
进行中（未招募）
4 期
The effect of zolendronic acid on the clinical resolution of acute midfoot Charcot footCharcot neuroarthropathy in patients with diabetes mellitusMusculoskeletal - Other muscular and skeletal disordersMetabolic and Endocrine - DiabetesACTRN12611000065998Pirkanmaa Hospital District40
终止
1 期
Perioperative Treatment With Zoledronic Acid in Patients With Resectable Pancreas CancerAdenocarcinomaNCT00892242Washington University School of Medicine24
已完成
2 期
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate CancerBone LossProstate CancerNCT00181584Massachusetts General Hospital60