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 sites21 target enrollmentJune 12, 2018

Overview

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

Registry

who.int

Start Date

June 12, 2018

End Date

August 31, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•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