EUCTR2010-020081-22-GB进行中（未招募）不适用
The administration of Parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: A prospective randomised comparative pilot study with blinded objective functional outcome assessment. - Parathyroid Hormone in the recovery from hip fractures - a pilot study
orth Bristol NHS Trust0 个研究点开始时间: 2010年12月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants must be 60 years and over admitted to North Bristol NHS Trust with a pertrochanteric femoral fracture.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients fulfilling any of the following criteria would be excluded from the trial.
- •1.Fracture not result of low energy trauma e.g fall from standing height
- •2.Conservative treatment
- •3.Surgical fixation with THR, hemiarthroplasty or cannulated screws
- •4.Previous treatment with PTH or other PTH analogues
- •5.Previous IV bisphosphonates e.g Zoledronic acid infusion in the previous 12 months
- •6.Previous treatment with Strontium in the previous 12 months
- •7.Current medications for breast and prostrate cancer (e.g tamoxifen, anastrozole, zoladex, prostap) or other current hormone therapy e.g. testerone, HRT
- •8.Decreased capacity to understand and the weigh the risks and benefits of participating in the trial
- •9.Presence of a metabolic bone disease e.g. Pagets disease of hyperparathyroidism
- •10.High or Low corrected calcium which requires investigation
- •11.Severe renal failure, urolithiasis or hypercalcaemia
- •12.Unexplained raised alkaline phosphatase
- •13.Active cancer diagnosis or skeletal malignances or bone metastases, or prior external beam or implant radiation therapy to skeleton within the last five years
- •14.Pre-menopausal, Pregnancy or lactation
- •15.Sustained use of oral steroids
- •16.Wheelchair, bed bound or transfers only prior to fracture
- •17.Other fractures that will affect ability to mobilise at 6 weeks
- •18.Physical capability to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other severe disabilities limiting manipulation injection pen and without appropriate carer willing and able to assist)
- •19.Patient consents to study >7 days post surgery
- •20.Patients currently involved in other clinical trial of medicinal products
研究者
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