E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early stage (Ficat 1 or 2), symptomatic, Avascular Necrosis (AVN) of the femoral head |
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E.1.1.1 | Medical condition in easily understood language |
Severe hip pain which may cause problems with function |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10005959 |
E.1.2 | Term | Bone disorders (excl congenital and fractures) |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess the short and long term effect of oral Bisphosphonate treatment (Alendronate) on Avascular Necrosis of the hip.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to: 1. Measure hip function, quality of life, radiological progression, complications and compliance with the treatment. 2. Assess the cost implications of the treatment arms and compare the cost-effectiveness at one year of active treatment versus placebo
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Short term outcome - Oxford Hip Score at 12 months post randomisation Long term outcome - Time to decision for total hip replacement at 36 months post randomisation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
OHS at 12 months after randomisation and time to decision for hip replacement will be assessed at 36 months after randomisation |
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E.5.2 | Secondary end point(s) |
To measure hip function using the OHS and iHOT-33 (a validated patient reported outcome measure specifically for younger patients), quality of life using the the EQ-5D and the Hospital Anxiety and Depression Score (HADS), radiological progression through X-ray and MRI, compliance using a compliance questionnaire and complication rates from safety reporting. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Hip function (OHS and iHOT-33) and quality of life (EQ-5D and HADS) will be assessed at baseline, 6, 12, 24 and 36 months Routine X-ray scans at 12 months and 36 months Routine MRI scans at 36 months Compliance questionnaire at 1, 2, 3, 6, 9 and 12 months Safety reporting as and when reported and flagged at 6, 12, 24 and 36 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is defined as 45 days after the final participant questionnaire has been delivered, and all the data has been entered and queries resolved. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 1 |