Eficacia y seguridad de una administración oral diaria de S06911 (combinación fija de ranelato de estroncio 2g / vitamina D3 1000UI) en la deficiencia de vitamina D para el tratamiento de la osteoporosis en mujeres postmenopáusicas y hombres Estudio internacional, de fase III, prospectivo, de 12 meses de duración en abierto con un grupo de tratamiento. The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D deficiency in the treatment of osteoporotic postmenopausal women and men. A 12 month, prospective, open labelled, one treatment group international phase III study.

Conditions: Osteoporosis en hombres y mujeres postmenopáusicas
MedDRA version: 9Level: LLTClassification code 10031283Term: Osteoporosis fracture
MedDRA version: 9Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

Registration Number: EUCTR2009-014270-18-ES

Lead Sponsor: aboratorios Servier S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Eficacia de S06911 en pacientes con niveles deficientes de vitamina D sérica / Efficacy of S6911 in patients with deficient vitamin D serum level;Secondary Objective: Recoger información sobre la seguridad y tolerabilidad de S06911 / To collect information on safety and tolerability of S6911;Primary end point(s): - nivel de vitamina D3 / vitamin D3 level

Secondary Outcome Measures