Treatment of postmenopausal Osteoporosis to reduce the risk of hip and vertebral fractures MedDRA version: 9.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . Women of at least 50 years . Postmenopausal for at least 3 years . Osteoporotic: - T-score at the L1-L4 spine and /or Femoral Neck inferior or equal to -2.5 SD, corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 inferior or equal to 0.772 g/cm² and/or a femoral neck mean BMD inferior or equal to 0.572 g/cm² for Hologic apparatus, or corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 inferior or equal to 0.880 g/cm² and/or a femoral neck mean BMD inferior or equal to 0.680 g/cm² for LUNAR apparatus . or - T-score at the L1-L4 spine and /or Femoral Neck inferior or equal to -1 SD and at least one prevalent low trauma fracture, corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 inferior or equal to 0.937 g/cm² and/or a femoral neck mean BMD inferior or equal to 0.738 g/cm² for Hologic apparatus, or corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 inferior or equal to 1.060 g/cm² and/or a femoral neck mean BMD inferior or equal to 0.860 g/cm² for LUNAR apparatus. At least 2 vertebrae must be assessable between L1 and L4 ; if less than 2 vertebrae are assessable, the T-score will be considered only at the Femoral Neck. 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
Exclusion criteria: . Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side . Previous and concomittant treatments interfering with bone metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: .To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with alendronate on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for 1 year.;Secondary Objective: .To assess the effects of strontium ranelate on bone histomorphometry parameters of formation, resorption, structure .To assess the effects of strontium ranelate on histomorphometry parameters including safety parameters, secondary mineralization, bone microarchitecture, bone markers, BMD;Primary end point(s): Cancellous Mineralizing Surfaces | — |
Countries
Belgium, Czech Republic, Estonia, France, Hungary, Italy, Netherlands, United Kingdom
Outcome results
None listed