Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in Radiological healing on radiographs
研究概览
简要总结
This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with age =/> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF.
- •ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails.
排除标准
- •Patients with metabolic bone diseases.
- •Patients with pathological fractures like tumor, osteopetrosis etc.
- •Patients with prior Ischemic heart diseases and underwent PCI or CABG
研究组 & 干预措施
Strontium group
Trial drug given in the form of sachet 2gm/sachet once every day
干预措施: Strontium Ranelate (Drug)
Placebo (Lactose)
Look, smell, taste alike lactose 2gm/sachet in form of sachet
干预措施: Lacto-N-Hexaose (Drug)
结局指标
主要结局
change in Radiological healing on radiographs
时间窗: 12 weeks and 24 weeks
Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks
次要结局
- change Bone mineral density through DEXA scan(pre-operatively or peri-admission and at 3 months)
研究者
Dr. Marij Zahid
Instructor orthopedic surgery
Aga Khan University Hospital, Pakistan