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临床试验/NCT01104324
NCT01104324Unknown不适用

Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Halton, Jacqueline, M.D.10 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
130
试验地点
10
主要终点
osteonecrosis 1 year post leukemia therapy

研究概览

简要总结

Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Enrollment in the STOPP-CIS study
  • Informed consent of patient or care givers
  • >5 years of age at MRI assessment

排除标准

  • Individuals with a history of claustrophobia precluding MRI assessment

结局指标

主要结局

osteonecrosis 1 year post leukemia therapy

时间窗: One year after completion of therapy for leukemia

Each participant will undergo MRI of hip, knee, ankle and shoulder to look for ON

次要结局

  • Methotrexate dose and ON(One year post leukemia therpy)
  • Obesity and ON(One year post leukemia therapy)
  • Bone mass density and Osteonecrosis(One year post therapy for leukemia)
  • Is Bone loss/failure to accure bone mineral and ON(One year post leukemia therapy)
  • Glucocorticoid dose and ON(One year post Leukemia therapy)
  • Weight bearing and non weight bearing activities and ON(One year post leukrmia therapy)
  • Hyperlipidemia and On(One year post leukemia therapy)
  • Thrombophilia and ON(One year post leukemia therapy)

研究者

发起方
Halton, Jacqueline, M.D.
申办方类型
Other

研究点 (10)

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