Prevention of Post Operative Bone Loss in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
研究概览
简要总结
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density
Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.
详细描述
Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora
Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D
Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group
Repeat DXA scan after end of immobilization or non-weightbearing
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta
- •lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks
排除标准
- •creatinine >1.2
- •prior bisphosphonate exposure
- •orthopaedic implants in distal femoral precluding DXA scan
- •inability to cooperate with DXA scan
研究组 & 干预措施
A recieveds pamidronate 1mg/kg once
Receives pamidronate 1mg/kg once
干预措施: pamidronate (Drug)
B: placebo group recieves saline
receives saline injection 10 cc/kg over 4 hours once post operatively
干预措施: saline (Other)
结局指标
主要结局
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
时间窗: Preoperative to post-operative DXA scan (4-12 weeks)
Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD
次要结局
未报告次要终点