EUCTR2017-002798-21-GB进行中（未招募）1 期
A multi-centre, blinded, randomised, placebo-controlled trial assessing the clinical and cost effectiveness of a 12 month course of oral alendronate (70mg weekly) in patients presenting with avascular necrosis of the hip - Managing Avascular Necrosis Treatments: an Interventional Study (MANTIS) - MANTIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
入选标准
- •Patients will be eligible for inclusion into the trial if:
- •1. They have early symptomatic atraumatic AVN of the hip (Ficat Score 1 or 2 using MRI)
- •2. They are aged greater than or equal to 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Patients will be excluded from this trial if they have/are:
- •1. Not confirmed their diagnosis (Ficat 1 or 2), using MRI, within the last 12 months
- •2. Renal function (creatinine clearance) of <30ml/min (tested within the last 3 months)
- •3. Adjusted serum calcium levels outside local reference range (tested within the last 3 months)
- •4. Established osteoarthritis (Kellgren-Lawrence =2)
- •5. Previous AVN, femoral head deformity, prior hip surgery or hip fracture in the index hip
- •6. Current pathology (e.g. osteoporosis) that requires treatment with bisphosphonates
- •7. Received previous anti-osteoporosis therapy (excluding calcium or vitamin D supplements) that lasted more than 4 weeks for oral treatment or any length of parenteral treatment
- •8. Contraindications to MRI
- •9. Contraindications to alendronate therapy (including hypocalcaemia) as listed in the SmPC
- •10. Planning a pregnancy in the next 12 months or are currently pregnant or breastfeeding
- •11. Not using appropriate contraception and of child bearing age
- •12. A planned joint preserving surgical procedure of the hip
- •13. Unable to provide informed consent
- •14. Unable to commit to follow-up regime
- •15. Already enrolled in an interventional clinical trial
研究者
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