E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Reducción de la pérdida ósea periprotésica en pacientes con artroplastia total de cadera por coxartrosis |
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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 | PT |
E.1.2 | Classification code | 10052306 |
E.1.2 | Term | Periprosthetic osteolysis |
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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 |
Mostrar la eficacia de ranelato de estroncio frente a placebo en la reducción de la pérdida ósea periprotésica en la región 7 de Gruen tras 12 meses de tratamiento después de una artroplasia total de cadera |
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E.2.2 | Secondary objectives of the trial |
Demostrar la eficacia de ranelato de estroncio frente a placebo en la reducción de la pérdida ósea periprotésica en La región de interés proximal en la región de interés total y en las regiones de 1 a 6 de Gruen, respectivamente, tras 12 meses de tratamiento. Evaluar la eficacia de ranelato de estroncio frente a placebo en los mismos criterios descritos previamente tras 6 meses de tratamiento. Evaluar la seguridad clínica y biológica de ranelato de estroncio tras 12 meses de tratamiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Hombre o mujer, raza caucásica con edades > =50 años (no hay limite superior de edad), estado posmenopáusico para mujeres, artroplastia total de cadera primaria convencional , vastago femoral no cementado, coxartrosis primaria como indicación de AT |
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E.4 | Principal exclusion criteria |
Vástago femoral corto (i.e. que conserva el cuello)Cualquier complicación perioperatoriaPacientes con artropatía inflamatoria, Riesgo aumentado de tromboembolismo venoso, Riesgo aumentado de tromboembolismo venoso, Imposibilidad de realizar DXA, Contraindicación conocida al tratamiento con Calperos D3®, Contraindicación conocida o hipersensibilidad al tratamiento del estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cambio relativo entre el valor basal y el último valor post basal hasta M012 (END) de DMO periprotésica en la región 7 de Gruen tras artroplastia total de cadera |
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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 | No |
E.6.4 | Safety | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The last visit last patient as stated in the study protocol. La última visita del último paciente tal y como está definido en el protocolo |
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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 | 2 |
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 | 2 |
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 |