ISRCTN03362357已完成不适用
The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment
orth Bristol NHS Trust (UK)0 个研究点目标入组 40 人开始时间: 2011年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients admitted to Frenchay Hospital with diagnosis of a pertrochanteric femoral fracture over the age of 60 years (either sex)
排除标准
- •Patients with any of the following would be excluded from the trial:
- •1. Fracture not as a result of a low energy injury/fall for example fall from standing height
- •2. Patients whose fracture is managed conservatively
- •3. Surgical fixation with total hip replacement (THR), hemiarthoplasty or cannulated screws
- •4. Previous treatment with PTH or other PTH analogues.
- •5. Hypersensitivity to the active substance or to any of the excipients.
- •6. Previous IV bisphosphonate (e.g. Zoledronic acid) in the previous 12 months
- •7. Strontium therapy for osteoporosis within the previous12 months
- •8. Current medications for breast and prostate cancer (e.g. tamoxifen, anastrozole, zoladex, prostap) or other hormone therapies such as testosterone, HRT
- •9. Decreased capacity to understand the risks of participating in the trial,
- •10. Metabolic bone disease e.g. Pagets disease & hyperparathyroidism other than primary osteoporosis or glucorticoid-induced osteoporosis.
- •11. Pre-existing hypercalcaemia or high or low corrected calcium which requires investigation.
- •12. Severe renal failure (EGFR <30) or urolithiasis
- •13. Unexplained raised alkaline phosphatase,
- •14. Active cancer diagnosis or skeletal malignancies or bone metastases or prior external beam or implant radiation therapy to skeleton within the last five years.
- •15. Premenopausal
- •16. Pregnancy or lactation
- •17. Sustained use of oral steroids
- •18. Wheelchair, bed bound or transferring only prior to fracture
- •19. Other fractures that will affect ability to mobilise at 6 weeks
- •20. Physically incapable to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other severe disabilities limiting manipulation of injection pen and without appropriate carer willing and able to assist)
- •21. Patient consents to study >7 days post surgery
- •22. Current participation in any other clinical trial of medicinal product
研究者
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