A double blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week on bone remodelling and bone safety assessed by histomorphometry in women with post menopausal osteoporosis - ND
- Conditions
- TREATMENT OF POST-MENOPAUSAL OSTEOPOROSISMedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2006-005581-39-IT
- 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 potentilly could lead an impossibility to perform a transiliac bone biopsy on each side. Previous and concomitant 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 patient with postmenopausal osteoporosis treated for 1 year.;Secondary Objective: To assess the effects of strontium ranelate on bone histomorphometry parameters of formation, resorption, structure including safety parameters, secondary mineralization, bone microarchitecture, bone markers, BMD.;Primary end point(s): Bone formation parameter measured by histomorphometry of Cancellous Mineralizing Surfaces
- Secondary Outcome Measures
Name Time Method