Efficacy and safety of strontium ranelate/vitamin D3 combination on vitamin D insufficiency in the treatment of osteoporotic patient.

• Conditions: Osteoporotic men and postmenauposal women; MedDRA version: 13.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 13.1Level: LLTClassification code 10031283Term: Osteoporosis fractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-09
• Last Update Posted: 11 August 2014

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 305
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 213

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of S6911 after 3 months of treatment;Secondary Objective: - To assess the efficacy of S6911 on vitamin D insufficiency<br>- To collect information on safety and tolerability of S6911;Primary end point(s): Evaluate the serum 25-OH Vitamin D levels over 3 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Vitamin D levels.<br>Change of BMD.<br>Safety and tolerability.;Timepoint(s) of evaluation of this end point: Evaluate the serum 25-OH vitamin D levels after 6 months.<br>BMD from baseline to 12 months.<br>Evaluate the safety at M1 and each 3 months.