ISRCTN66814619已完成未知
Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases
Greenpark Healthcare Trust (UK)0 个研究点目标入组 300 人开始时间: 2005年9月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Children and adolescents with JIA, JSLE, JDM, commencing steroids or currently treated with steroids between the ages of 4 and 18 years
排除标准
- •1. Children who are commencing steroids but where the duration of steroid treatment is expected to be less than 3 months (i.e. short term) should not be recruited
- •2. Children receiving intermittent pulses of intravenous steroids
- •3. Co-morbid conditions known to be associated with osteopaenia: Cystic fibrosis, malabsorption, severe renal disease, severe asthma, cancer, osteogenesis imperfecta, inflammatory bowel disease
- •4. Have a history of using any bisphosphonate (except for more than a single dose of risedronate) and/or fluoride (>10 mg per day)
- •5. Have a history of cancer
- •6. Have untreated rickets within one year prior to enrolment
- •7. Evidence of clinically significant organic or psychiatric disease on history or physical examination which in the opinion of the investigator would prevent the patient from completing the study
- •8. Have markedly abnormal pretreatment laboratory findings, except if in the opinion of the investigator, it would not prevent the patient from completing the study
- •9. Have a history of using anabolic steroids/estrogens/androgens within one year of enrolment
- •10. Have a documented history of an abnormal or allergic reaction to bisphosphonates
- •11. Pregnancy or sexually active subjects unwilling to take appropriate contraceptive measures
- •12. Any limb-lengthening procedure within 6 months of enrolment
- •13. Participation in another clinical trial, involving active intervention within 30 days prior to enrolment
- •14. Creatinine clearance <100 ml/min
研究者
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