The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.

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

• Registration Number: EUCTR2009-013935-39-AT
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-11
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

- Osteoporotic men and postmenopausal osteoporotic women
- Superior or equal to 50 year
- Caucasian
- Body mass index inferior to 30 kg/m2
- 25-OH vitamin D concentration >22.5 nmol/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

- Progressive major illness, uncontrolled active disease, skeletal disease
- History or increased risk of deep venous thrombosis or pulmonary embolism
- History of intolerance, allergy or severe hypersensitivity with study drugs
- History of alcohol abuse or drug dependance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified