Managing Avascular Necrosis Treatments: an Investigational Study (MANTIS)

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14015902

Enrollment

280

Registered

2018-06-12

Start date

2018-07-15

Completion date

Unknown

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular necrosis of the hip Musculoskeletal Diseases Osteonecrosis

Interventions

Randomisation will be performed using a minimisation algorithm including random elements to ensure balanced allocation of participants across the two treatment groups stratified by: 1.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Diagnosis not confirmed their diagnosis (Ficat 1 or 2), using MRI, within the last 12 months 2. Renal function (creatinine clearance) of =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

Design outcomes

Primary

Measure	Time frame
Hip function measured using Oxford Hip Score (OHS) at 12 months	—

Secondary

Measure	Time frame
1. Hip function and quality of life (QoL) measured using Oxford Hip Score (OHS), iHOT-33, Hospital Anxiety and Depression Score (HADS) and EQ-5D-5L at baseline, 6, 12, 24 and 36 months 2. Radiological progression measured using x-ray at 12 and 36 months and MRI at 36 months 3. Treatment compliance measured using bespoke compliance questionnaires at 1, 2, 3, 6, 9, and 12 months 4. Cost effectiveness measured using healthcare resource use questionnaires at 6, 12, 24 and 36 months	—

Measure

Time frame

1. Hip function and quality of life (QoL) measured using Oxford Hip Score (OHS), iHOT-33, Hospital Anxiety and Depression Score (HADS) and EQ-5D-5L at baseline, 6, 12, 24 and 36 months 2. Radiological progression measured using x-ray at 12 and 36 months and MRI at 36 months 3. Treatment compliance measured using bespoke compliance questionnaires at 1, 2, 3, 6, 9, and 12 months 4. Cost effectiveness measured using healthcare resource use questionnaires at 6, 12, 24 and 36 months

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026