"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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014270-18-ES

Enrollment

Registered

2009-11-02

Start date

2010-01-13

Completion date

Unknown

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: S06911 Product Code: S06911 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: ranelato de estroncio CAS Number: 135459-90-4 Current Sponsor code: S12911 Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Belgium, Denmark, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026