E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Der undersøges osteoportiske sammenfald i columna thoracolumbalis (Th6-L5), og den smertelindrende effekt ved insprøjtning af lidocain ind i vertebrae versus indsprøjtning af cement. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031283 |
E.1.2 | Term | Osteoporosis fracture |
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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 |
At sammenligne den smertelindrende effekt over en 1 årig periode mellem PVP og en sham-procedure ved frakturer i nedre thorakal columna (th8-th12) samt hele columna lumbalis, ved akut opståede (max 8 uger) smertefulde osteoporotiske sammenfald. |
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E.2.2 | Secondary objectives of the trial |
At undersøge stabiliteten af rygsøjlen efter udførte indgreb, målt på højdereduktion, og kyfosering på lateral røntgenoptagelse.
At undersøge hvorvidt der er en forskel i lungefunktion hos patienterne i de to grupper (PVP/sham)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Osteoporotisk – suspekt eller manifest – vertebral sammenfald/fraktur, lavenergi på niveau Th6-L5 Smerter på mindst 6 (af 10) på en VAS ved inklusionssamtale. Eventuel smertedækning i form af håndkøbs smertestillende medicin er tilladt. Smertevarighed på max 8 uger. Alder over 50 år og for kvinder menopause Ingen demens vurderet ved MMSE (24 af 30 korrekte svar) Ødem påvist ved MR-scanning
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E.4 | Principal exclusion criteria |
Ukorrigeret AK behandling Infektion, antibiotikabehandlet Påvist malign sygdom Allergi overfor røntgenkontrast Samtidig fraktur af lange rørknogler Allergi overfor Lidokain
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E.5 End points |
E.5.1 | Primary end point(s) |
VAS-score (1-10). Der anvendes VAS skala, hvor 1 er ingen smerter og 10 er uudholdelige smerter. Forsøgspersonen får udleveret skalaer med henblik på registrering af smerte under interview og aflevering ved besøg 3 mdr. Ved 12 mdr. interview registreres smerte efter udelukkende mundtlig oplysning fra forsøgspersonen,
SF-36
EQ5D (QALYs)
Røntgen: stående lateraloptagelse af columna totalis
Lungefunktionsundersøgelse målt på spirometer, ved inklusion samt efter 3 & 12 mdr. (FEV1, FVC, FEV1/FVC)
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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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
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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Forsøget er slut når minimum 2 x 26 personer er blevet fulgt i 1 år efter operation. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |