E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031282 |
E.1.2 | Term | Osteoporosis |
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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 |
Determinar la eficacia del ácido zoledrónico administrado vía parenteral (endovenoso) anualmente, como tratamiento de la osteoporosis, evaluando las variaciones en la densidad mineral ósea, determinada por densitometría radiológica de doble energía (DEXA). |
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E.2.2 | Secondary objectives of the trial |
Evaluar la seguridad y tolerabilidad del ácido zoledrónico Evaluar los cambios en los marcadores de formación y de reabsorción ósea con ácido zoledrónico endovenoso anual. Determinar la prevalencia global de osteopenia/osteoporosis en los pacientes con infección VIH de nuestro medio. Determinar las diferencias en la masa mineral ósea según el tiempo y tipo de tratamiento antirretroviral, así como en los pacientes sin experiencia al tratamiento antirretroviral. Determinar los factores predisponentes de osteopenia/osteoporosis en esta población (edad, sexo, IMC, alcohol, antirretrovirales, tiempo de infección, tratamiento hormonal sustitutivo, menopausia, etc). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Edad igual o superior a 18 años. 2. Infección documentada por VIH-1, con o sin tratamiento antirretroviral. 3. Presencia de criterios de osteoporosis según la OMS, definido como t-score menor de 2,5 en columna lumbar, cadera y/o trocánter. (Se requiere DEXA confirmatoria dentro de los 6 meses anteriores a la visita basal) 4. Disponibilidad para seguir el protocolo. 5. Firma del consentimiento informado |
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E.4 | Principal exclusion criteria |
1. En caso de mujeres, gestación o lactancia materna. 2. Otras posibles causas de osteoporosis secundaria o hipocalcemia. 3. Creatinina superior a 2,3 mg/mL 4. Filtrado glomerular menor a 50 mL/min (estimado a partir de la ecuación de MDRD) 5. Tratamiento para la osteoporosis durante los últimos 4 meses. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incremento en la densidad mineral ósea t-score lumbar (L2-4) y femoral (trocánter, cuello femoral, cadera y fémur total). Acontecimientos adversos. Parámetros de laboratorio. Eventos clínicos relacionados (fracturas óseas). Actividad osteoblástica/osteoclástica, marcadores de formación/reabsorción 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 | 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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Medidas higiénico-dietéticas |
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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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |