A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT). - ND

• Conditions: postmenopausal osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2007-001509-11-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Post-menopausal (for at least 5 years)women 50 years old , ambulatory, capable of understanding the study , having given their written informed consent; diagnosis of osteoporosis: T- score measured by DXA < or =-2.5 at either femoral neck, or the total hip or the lumbar level (L1-L4).
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

Patient who are: unlikely to co-operate in the study, with movement disorders which could intefere during the p-QCT measurement, evolutive cancers during the past 5 years with a risk of bone metastases, BMI less than 18 or higher than 30 Kg/m2. Severe malabsorption. Previous and concomitatn treatment 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 strontium ranelate (2g/day)(with calcium 500 mg/day and Vitamin D 400 IU/day supplements) in comparison with alendronate (70mg/week)(with calcium 500 mg/day and Vitamin D 400 IU/day supplements) on the bone geometry and bone strength in patients with postmenopausal osteoporosis.;Secondary Objective: Cortical, trabecular and total bone content and density. Lumbar and hip BMD assessed by DXA. Bone markers;Primary end point(s): Measurement of geometrical and bone strength parameters by p-QCT.