E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis |
Osteoporosis |
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E.1.1.1 | Medical condition in easily understood language |
Osteoporosis |
Osteoporosis |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031282 |
E.1.2 | Term | Osteoporosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
To collect and assess safety information for the double-blinded treatment period ending 5 years post-randomization regarding deaths, SAEs, adverse events requiring adjudication, and skin ECIs in subjects who were randomized and tookat least one dose of blinded study medication, then discontinued from study drug but have not completed follow-up through the 5-year blinded treatment period of Protocol 018 and its 1stextension. These data will be analyzed togetherwithdata fromsubjects who have completed 5 years of blinded study medication |
Recoger y evaluar datos de seguridad del periodo de tratamiento doble ciego de 5 años tras la aleatorización con relación a muertes, AAG, AA adjudicables y AIC cutáneos en pacientes aleatorizadas que tomaron al menos una dosis de la medicación enmascarada del estudio antes de interrumpir el tratamiento del estudio y no completaron el seguimiento hasta el final del período de tratamiento ciego de 5 años del protocolo 018 y su primera extensión. Estos datos se analizarán junto con los datos de las pacientes que hayan completado los 5 años de tratamiento ciego del estudio. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible for participation in this trial, the subject must: 1.Have been randomized into Protocol 018 2.Have taken at least 1 dose of blinded study medication 3.Have discontinued from Protocol 018 base study prior to study close-out OR have completed the base study of Protocol 018 and did not continue into the 1st extension of Protocol 018 OR have discontinued the 1st extension study (Protocol 018-10/Protocol 018-05) prior to reaching the open-label portion of the study OR have discontinued the amended 1st extension study (Protocol 018-06) prior to reaching the open-label period of the study and did not consent to continue follow-up clinic visits and study procedures. |
Para poder participar en este ensayo, las pacientes deberán: 1.Haber sido aleatorizadas en el protocolo 018. 2.Haber tomado al menos 1 dosis del fármaco enmascarado del estudio. 3.Haber discontinuado del estudio base del protocolo 018 antes del cierre del estudio O haber completado el estudio base del protocolo 018 sin continuar después en la primera extensión del protocolo 018 O haber discontinuado del primer estudio de extensión (protocolo 018 10/protocolo 018 05) antes de llegar al período abierto del estudio O haber discontinuado del primer estudio de extensión modificado (protocolo 018 06) antes de llegar al período abierto del estudio sin dar el consentimiento para continuar con las visitas y procedimientos de seguimiento del estudio. |
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E.4 | Principal exclusion criteria |
The subject must be excluded from participating in the trial if the subject: 1.Had her Protocol 018 treatment group assignment unblinded, prior to the open-label period 2.Has discontinued treatment after she entered into the open-label period |
No podrán participar en el ensayo las pacientes: 1.Cuyo grupo de tratamiento asignado en el protocolo 018 fue desenmascarado antes del período abierto. 2.Que interrumpieron el tratamiento después de entrar en el período abierto. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The overall trial ends when the last subject?s reportable event has either resolved or met stabilization criteria (see flowchart footnote 7) after all reportable events have been collected at Month 60 or has been lost to follow-up (i.e. the subject is unable to be contacted by the investigator). |
El ensayo finaliza cuando el último acontecimiento notificable de una paciente, tras el registro de todos los acontecimientos notificables en el mes 60, se haya resuelto o cumpla los criterios de estabilización (véase la nota al pie 7 del diagrama de flujo), o se haya perdido para el seguimiento (es decir, el investigador no puede ponerse en contacto con la paciente). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Month 48 and Month 60 after randomization into the main Protocol 018 base study. |
Mes 48 y el mes 60 después de aleatorización de la paciente en el estudio base del protocolo 018. |
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E.5.2 | Secondary end point(s) |
not applicable |
No aplica. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
No aplica. |
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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 | 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) | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
No se administrará ningún tratamiento activo este estudio observacional de seguimiento |
No study medication will be given for this observational follow-up study |
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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 | Yes |
E.8.2.3.1 | Comparator description |
No se administrará ningún tratamiento activo este estudio observacional de seguimiento |
No study medication will be given for this observational follow-up study |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 116 |
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 | No |
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 |
Serbia |
Argentina |
Belgium |
Brazil |
Bulgaria |
Chile |
China |
Colombia |
Czech Republic |
Denmark |
Dominican Republic |
Estonia |
France |
Germany |
Guatemala |
Hong Kong |
India |
Italy |
Japan |
Korea, Republic of |
Latvia |
Libyan Arab Jamahiriya |
Lithuania |
New Zealand |
Norway |
Spain |
Mexico |
Peru |
Philippines |
Poland |
Romania |
Russian Federation |
South Africa |
Switzerland |
Taiwan |
Ukraine |
United Kingdom |
United States |
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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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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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |