A Comparative Study of Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty in Patients With Osteoporotic Femoral Neck Fractures
试验速览
- 阶段
- 4 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- de Morton Mobility Index
研究概览
简要总结
Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.
详细描述
Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.
This study aims to compare functional recovery between early- and late administration of bisphosphonate in patients who received hemiarthroplasty following femoral neck fractures.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with femoral neck fracture and was treated with bipolar hemiarthroplasty
- •Age more than 50 years old and bone mineral density (BMD) was in osteoporotic (T-score less than -2.5) or osteopenic (T-score between -1.0 and -2.5) ranges
排除标准
- •Patients who were treated with bipolar hemiarthroplasty for more than 2 weeks
- •Patients with postoperative complications which affect the postoperative rehabilitation program e.g. intraoperative cracking or fracture, postoperative cardiac complication
- •Have contraindications for bisphosphonates use e.g. renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min), allergy to bisphosphonates, severe esophagitis, gastroesophageal reflux disease etc.
- •Patients with conditions/disorders which have an affect on bone mineral density or bone metabolism e.g. renal insufficiency, rheumatoid arthritis, Paget's disease, renal osteodystrophy, hyperparathyroidism, glucocorticoids use etc.
- •History of bisphosphonates use within 12 months
- •Open fracture, multiple fracture or multiple trauma patients
- •Pathological fracture
- •Bilateral lower extremity fractures
- •The pre-injury functional status of the patients is non-ambulatory
研究组 & 干预措施
Early bisphosphonate use
Give risedronate (actonel) at 2 weeks after hemiarthroplasty for an osteoporotic femoral neck fracture. In addition, calcium and vitamin D supplementation will be given to all patients.
Risedronate (35 mg) 1 tablet orally once a week
干预措施: Risedronate (Drug)
结局指标
主要结局
de Morton Mobility Index
时间窗: 3 months after surgery
次要结局
- Visual analog scale score(3 months after surgery)
- Two minutes walking test(3 months after surgery)
- Timed get up and go test(3 months after surgery)
- Barthel index(3 months after surgery)
- EuroQoL-5D (EQ-5D)(3 months after surgery)