E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024124 |
E.1.2 | Term | Leg amputation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Investigate the possibility to optimize patients' rehabilitation progress through the assessment of BMD at the OI-prosthesis and prescription of denusomab
H1: BMD increases in the group Denusomab (DXA) compared to controls. |
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E.2.2 | Secondary objectives of the trial |
H2: Improved prosthetic fixation (RSA) in Denusomab group.
H3: Better early mobilization (up to 1 year)
H4: bone activity increases within three days post-operative |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed consent,
Age 18-70 years,
candidate for the OI-prosthesis (eg after traumatic amputation or because of tumor),
BMI <30, normal bone structure except for reduced BMD. |
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E.4 | Principal exclusion criteria |
Diabetes or metabolic disease, atherosclerosis, smoking, drug abuse, treatment with NSAIDs or active treatment with cytotoxic drugs, active cancer, liver or renal impairment, dementia, pregnancy, decreased hip movement on the affected side> 10 degrees, body weight> 100 kg. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.BMD measured pre-and postoperative in the lumbar spine and bilaterally in the femoral neck prosthesis with DXA (primary endpoint). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
First patient, first visit february 2013. Last patient last visit february 2016 |
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E.5.2 | Secondary end point(s) |
2.Stability (security parameter, a secondary endpoint) studied using stereo x-ray analysis (RSA).
3. Oxygen consumption and gait velocity tested with gait analysis.
4.Postoperative cell activity (CTX (resorption) and PINP and BASP (formation) and OPG and RANKL) and growth factors monitored by collecting samples via microdialysis catheter |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
First patient, first visit february 2013. Last patient last visit february 2016 |
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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 | No |
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 | No |
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.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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when 14 patients have undergone operation, trial treatment and completed 1 year followup |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |