EUCTR2009-014270-18-ESActive, not recruitingNot Applicable
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.
aboratorios Servier S.L.0 sites60 target enrollmentStarted: November 2, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
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