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

Active, not recruiting

• Conditions: Osteoporotic men and osteoporotic postmenauposal women; MedDRA version: 14.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: LLTClassification code 10031283Term: Osteoporosis fractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Osteoporotic men and osteoporotic postmenopausal women
- Superior or equal to 50 year
- 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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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 S6911
- 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 S6911 in patients with deficient vitamin D serum level;Secondary Objective: To collect information on safety and tolerability of S6911;Primary end point(s): - vitamin D level;Timepoint(s) of evaluation of this end point: Evaluate the efficacy over 12 months of treatment on the correction of vitamin D insufficiency in patients with deficient vitamin D serum levels

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Vitamin D levels<br>Safety and tolerability;Timepoint(s) of evaluation of this end point: Evaluate the efficacy over 12 months of treatment on the correction of vitamin D deficiency.<br>Safety evaluation each 3 months