SOTI and TROPOS phase III studies open-label extension. The long term efficacy and long term safety assessment of a five-year oral administration of strontium ranelate in osteoporotic postmenopausal women having participated either in Spinal Osteoporosis Therapeutic Intervention SOTI study or TReatment Of Peripheral OSteoporosis TROPOS study. A five-year multicentric multinational open study with strontium ranelate.
Phase 3
Completed
- Conditions
- Postmenopausal osteoporosisMusculoskeletal Diseases
- Registration Number
- ISRCTN48348637
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22124575
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 3000
Inclusion Criteria
1. Caucasian women
2. Postmenopausal
3. Osteoporosis
4. Having participated up to the SOTI or TROPOS M060 visit or withdrawn under study treatment from the SOTI or TROPOS study within a 6-month period preceding the theoretical M060 visit
Exclusion Criteria
1. Patients having attended the M060 or withdrawn SOTI-TROPOS visit at a time greater than one year prior to the inclusion visit of the CL3-12911-012 protocol
2. Significant concomitant disease (evolutive major illnesses)
3. Severe disease interfering with bone metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following will be assessed annually during the treatment: <br>1. Dual X-ray absorptiometry (DXA) <br>2. Vertebral fractures radiographs in patients having had vertebral radiographs in SOTI or TROPOS <br>3. Occurrence of peripheral fractures
- Secondary Outcome Measures
Name Time Method Safety