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临床试验/NCT03301285
NCT03301285已完成不适用

Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月1日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change from baseline (before start of zoledronic acid treatment) lumbar bone density
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities.

Secondary purposes are:

  1. Description of child population with osteoporosis in the context of motor impairment in Lorraine region
  2. Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
  3. Description of current osteoporosis preventive care
  4. Description of risk factors associated to bone status (drugs)
  5. Evaluation of zoledronic acid treatment on fracture numbers
  6. Evaluation of zoledronic acid on phosphocalcic profile
  7. Description of side effects of zoledronic acid in this indication
  8. Description of treatment effects in the sub-population of children with Rett syndrome.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Non refusal of parents of participation of their child to the study
  • •Patients followed for multiple disabilities
  • •Osteoporosis: lumbar osteodensitometry z-score <-2.5 SD associated or not to pathologic fracture

排除标准

  • •Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)
  • •Absence of multiple disabilities

研究组 & 干预措施

Children with osteoporosis associated to multiple disabilities

Treated with zoledronic acid

干预措施: Zoledronic Acid (Drug)

结局指标

主要结局

Change from baseline (before start of zoledronic acid treatment) lumbar bone density

时间窗: through study completion, 4 years

reported in Z-score

次要结局

  • Weight(Baseline)
  • Administration of drugs or not(baseline)
  • Number of fractures after the start of zoledronic acid treatment(through study completion, 4 years)
  • Sex(Baseline)
  • Age(Baseline)
  • Height(Baseline)
  • Frequency of side effects(through study completion, 4 years)
  • Change from baseline lumbar bone density in sub-population of children with Rett syndrome after 1 year of zoledronic acid treatment(1 year from baseline)
  • Occurrence of bone fractures(Until baseline)
  • Long-term administration of vitamin/calcium supplement or not(baseline)
  • Change from baseline phosphocalcic profile evaluation(through study completion, 4 years)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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