E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pérdida ósea periprotésica precoz tras artroplastia total de cadera.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065687 |
E.1.2 | Term | Bone loss |
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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 |
Evaluar el efecto de la administración de ácido zoledrónico sobre la densidad mineral ósea del hueso periprotésico en la artroplastia de cadera. |
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E.2.2 | Secondary objectives of the trial |
Valoración de los marcadores del remodelado óseo en el grupo con ácido zoledrónico y el placebo. Densitometría femoral contralateral en ambos grupos. Incidencia de efectos adversos. Seguimiento radiológico del fémur intervenido para evaluar los cambios radiológicos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Hombres o mujeres con artrosis primaria o secundaria de cadera que precisen una prótesis total de cadera (PTC) unilateral o bilateral. - PTC no cementada - Capacidad para realizar un régimen fisioterapéutico tras la intervención. - El paciente comprende el procedimiento del estudio, está informado de tratamientos alternativos y está dispuesto a participar en el estudio. - El paciente puede realizarse la exploración densitométrica en el territorio definido. - Pacientes de ambos sexos entre 18 y 75 años de edad. |
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E.4 | Principal exclusion criteria |
- Enfermedades conocidas (exceptuando la osteoporosis primaria) o uso de fármacos con influencia en el metabolismo óseo, - Enfermedad inflamatoria articular. - Insuficiencia renal definida por unos valores de aclaramiento de creatinina < 35 ml/min. - Tratamiento durante el último año con corticoides, estrógenos, progestágenos, andrógenos o calcitonina. - Tratamiento previo con bifosfonatos o flúor ( excepto profilaxis dental). - Embarazo o periodo de lactancia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Masa ósea periprotésica medida con densitometría ósea |
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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 | 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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Information not present in EudraCT |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |