Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- changes from baseline of areal BMD at lumbar spine and total hip
研究概览
简要总结
Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI) because it significantly increased areal bone mineral density (BMD) and its Z score, decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted beneficial roles in different age brackets, especially in young patients with OI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •children or adolescents aged 0-18 years,
- •had either a history of at least once minor-impact fracture or age and sex adjusted areal BMD Z score of -1.0 or less at lumbar spine or total hip;
- •with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
- •with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films.
排除标准
- •previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
- •therapy history of BPs within recent two years; severe renal failure (creatinine clearance <40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
- •unable to keep upright for at least 30 minutes daily .
研究组 & 干预措施
an open label, prospective, self-controlled study
Children or adolescents under the age of 18 years old with minor trauma fracture were recruited from 30 provinces of China. The diagnosis of OI was made by endocrinology department of Peking Union Medical College Hospital(PUMCH).
干预措施: Alendronate (Drug)
结局指标
主要结局
changes from baseline of areal BMD at lumbar spine and total hip
时间窗: baseline and 12,24,36 months
annual clinical fracture incidence
时间窗: baseline and 12,24,36 months
次要结局
- changes of bone turnover biomarkers(baseline and 6,12,24,36 months)
- changes of height(baseline and 12,24,36 months)