E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis en hombres y mujeres postmenopáusicas |
|
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 | 10031283 |
E.1.2 | Term | Osteoporosis fracture |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031285 |
E.1.2 | Term | Osteoporosis postmenopausal |
|
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 |
Eficacia de S06911 en pacientes con niveles deficientes de vitamina D sérica / Efficacy of S6911 in patients with deficient vitamin D serum level |
|
E.2.2 | Secondary objectives of the trial |
Recoger información sobre la seguridad y tolerabilidad de S06911 / To collect information on safety and tolerability of S6911 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Hombres osteoporóticos y mujeres postmenopáusicas osteoporíticas / Osteoporotic men and osteoporotic postmenopausal women - Edad mayor o igual a 50 años / Superior or equal to 50 year - Indice de masa corporal inferior a 30kg/m2 / Body mass index inferior to 30 Kg/m2 - Concentración de 25oh-vitamina igual o < 22,5nmol/L / D 25OH-vitaminD concentration equal or < 22,5nmol/L |
|
E.4 | Principal exclusion criteria |
- Historia de enfermedad importante progresiva, enfermedad activa no controlada o enfermedad osea/ History of major illness, uncontrolled active disease, skeletal disease - Historia o riesgo elevado de tromboembolismo venoso profundo o embolismo pulmonar / History or increase risk of deep venous thrombosis or pulmonary embolism - Antecedentes de intolerancia, alergia o hipersensibilidad al ranelato de estroncio, vitamina D o excipientes del S06911 / History of intolerance, allergy or severe hypersensivity with strontium ranelate, vitamin D or excipients of S6911 - Historia de abuso de alcohol o drogodependencia / History of alcohol abuse or drug dependance |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- nivel de vitamina D3 / vitamin D3 level |
|
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 |
|
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
|
La definición de la última visita del último paciente se proporciona en el protocolo / The difinition of the last visit of the last patient is provided in the protocol |
|
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 | 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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |