ISRCTN62133820已完成未知
Fractures and Bisphosphonates: a double-blind, randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes in wrist fractures
niversity of Edinburgh (UK)0 个研究点目标入组 421 人开始时间: 2011年6月22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
- 421
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30845365 [added 12/04/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 19/09/2012:
- •1. Patients (male and female) aged 50 years and over
- •2. Patients must have suffered a distal radial fracture confirmed by X-ray radiograph
- •3. The distal radial fracture must be:
- •3.1. Unilateral extra-articular or minimal articular
- •3.2. Displaced or un-displaced
- •3.3. Treated with cast/splint, external fixation or open reduction and internal fixation
- •4. Patients willing and able to consent and comply with study protocol
- •Previous inclusion criteria until 19/09/2012:
- •3.3. Treated with cast, external fixation or open reduction and internal fixation
排除标准
- •Current exclusion criteria as of 19/09/2012:
- •1. Any of the following:
- •1.1. current or previous use of zoledronic acid
- •1.2. current or previous use within the last 2 years of any other bisphosphonate
- •1.3. current or previous use within the last 6 months of strontium ranelate, calcitonin, denosumab, parathyroid hormone (PTH) or intravenous (IV), intramuscular (IM) and oral corticosteroids (inhaled corticosteroids such as asthma inhalers are acceptable)
- •2. Previous distal radial fracture on affected side
- •3. Bilateral distal radial fracture
- •4. Contraindications to alendronic acid, including but not limited to:
- •4.1. Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achlasia
- •4.2. Inability to stand or sit upright for at least 30 minutes
- •4.3. Hypersensitivity to alendronate or any of its excipients
- •4.4. Known hypocalcaemia
- •4.5. Known renal impairment
- •5. Women of childbearing potential not using adequate contraception
- •6. Pregnancy
- •7. The distal radial fracture is due to other pathologies e.g. Paget?s Disease of Bone, metastatic bone disease etc.
- •Previous exclusion criteria until 19/09/2012:
- •1. Any of the following:
- •1.1. Current or previous use of zoledronic acid
- •1.2. Current or previous use within the last 2 years of any other bisphosphonate
- •1.3. Current or previous use within the last 6 months of strontium ranelate, calcitonin, denosumab, parathyroid hormone (PTH) or intravenous (IV), intramuscular (IM) and oral corticosteroids (inhaled corticosteroids such as asthma inhalers are acceptable)
- •2. Previous distal radial fracture on affected side
- •3. Bilateral distal radial fracture
- •4. Contraindications to alendronic acid, including but not limited to:
- •4.1. Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achlasia
- •4.2. Inability to stand or sit upright for at least 30 minutes
- •4.3. Hypersensitivity to alendronate or any of its excipients
- •4.4. Hypocalcaemia at baseline (serum adjusted calcium <2.2mmol/l)
- •4.5. Renal impairment at baseline [estimated glomerular filtration rate (eGFR) less than 35ml/min as assessed by the Modification of Diet in Renal Disease (MDRD) formula]
- •5. Women of childbearing potential not using adequate contraception
- •6. Pregnancy
研究者
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