A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
- Conditions
- MedDRA version: 9.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalTreatment of postmenopausal Osteoporosis to reduce the risk of hip and vertebral fractures
- Registration Number
- EUCTR2006-005581-39-NL
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 285
. Women of at least 50 years
. Postmenopausal for at least 3 years
. Osteoporotic:
T-score at the spine and /or hip inferior or equal to -2.5 SD
or
T-score at the spine and /or hip inferior or equal to -1 SD and at least one prevalent low trauma fracture
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
. 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
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 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<br>.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
- Secondary Outcome Measures
Name Time Method