Managing Avascular Necrosis Treatments: an Investigational Study (MANTIS)

Phase 1

• Conditions: Early stage (Ficat 1 or 2), symptomatic, Avascular Necrosis (AVN) of the femoral head; MedDRA version: 20.0 Level: HLGT Classification code 10005959 Term: Bone disorders (excl congenital and fractures) System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-002798-21-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-13
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified