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: Osteoporotic men and osteoporotic postmenauposal women; MedDRA version: 12.0Level: LLTClassification code 10031283Term: Osteoporosis fracture; MedDRA version: 12.0Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2009-014270-18-DK
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Osteoporotic men and osteoporotic postmenopausal women
- Superior or equal to 50 years
- Body mass index inferior to 30 Kg/m2
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

- History of major illness, uncontrolled active disease, skeletal disease
- History or increase risk of deep venous thrombosis or pulmonary embolism
- History of intolerance, allergy or severe hypersensivity with strontium ranelate, vitamin D or excipients of S06911
- 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: Efficacy of S06911 in patients with deficient vitamin D serum level;Secondary Objective: To collect information on safety and tolerability of S06911;Primary end point(s): - vitamin D3 level