Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Measure the change in the Bone densitometry due to secondary osteoporosis
研究概览
简要总结
Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children & adolescents treated for ALL in the Children's Cancer Hospital -Egypt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 5 & below 18 years at the time of diagnosis.
- •Newly diagnosed ALL patients.
- •Not previously treated, previous steroid intake not more than 72 hours.
- •Treated according to St Judy study XV protocol.
排除标准
- •Previous steroid intake more than 72 hours.
- •Less than 5 years
研究组 & 干预措施
Arm ( A)
Arm ( A) : patients will receive calcium & vitamin D
干预措施: calcium & vitamin D (Drug)
Arm (B)
we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
干预措施: zolendronic acid (Drug)
结局指标
主要结局
Measure the change in the Bone densitometry due to secondary osteoporosis
时间窗: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
we will do the following for evaluation : 1. Bone densitometry using Dual-energy x-ray absorptiometry (DXA) scan analyzed using the Z-score. To be done : * At baseline ( not more than 48 hours of start of therapy with steroids) * At week 48 * At end of treatment ( week 120 for girls ) \& ( week 146 for boys) * As required clinically eg: fractures . 2. Magnetic resonance imaging of both hips \& knees will be done at reinduction I \& II \& if symptomatic.
次要结局
- - To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.(week 48 continuation phase)