A multi-centre, blinded, randomised, placebo-controlled trial assessing the clinical and cost effectiveness of a 12 month course of oral alendronate (70 mg weekly) in patients presenting with avascular necrosis of the hip - Managing Avascular Necrosis Treatments: an Interventional Study (MANTIS)

niversity of Oxford0 个研究点目标入组 21 人开始时间: 2018年6月12日最近更新: 2022年11月14日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36321501/ (added 03/11/2022)

•1. Early, symptomatic, atraumatic AVN of the hip (Ficat score 1 or 2 using MRI)
•2. Aged 18 years or over

•1. Diagnosis not confirmed their diagnosis (Ficat 1 or 2), using MRI, within the last 12 months
•2. Renal function (creatinine clearance) of < 30 ml/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. Have 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

发起方