Efficacy and safety of strontium ranelate/vitamin D3 combination on vitamin D deficiency in the treatment of osteoporotic patient
Phase 3
Completed
- Conditions
- Osteoporosis, vitamin D deficiencyMusculoskeletal DiseasesOsteoporosis without pathological fracture
- Registration Number
- ISRCTN47943635
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
1. Osteoporotic men and osteoporotic post-menopausal women
2. Age superior or equal 50 years
3. Caucasian
4. 25-OH vitamin D3 serum concentration inferior or equal to 22.5 nmol/L
Exclusion Criteria
1. Progressive major illness
2. Uncontrolled active disease
3. Skeletal disease
4. History or increased risk of deep venous thrombosis or pulmonary embolism
5. History of intolerance, allergy or severe hypersensitivity with study drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br> 1. Evaluate the efficacy over 12 months of treatment on the correction of vitamin D deficiency<br> 2. Safety evaluation each 3 months<br>