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: Treatment of postmenopausal Osteoporosis to reduce the risk of hip and vertebral fractures; MedDRA version: 9.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2006-005581-39-HU
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-20
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 285

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 < 0.772 g/cm² and/or a femoral neck mean BMD < 0.572 g/cm² for Hologic apparatus, or corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 < 0.880 g/cm² and/or a femoral neck mean BMD < 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 < 0.937 g/cm² and/or a femoral neck mean BMD < 0.738 g/cm² for Hologic apparatus, or corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 < 1.060 g/cm² and/or a femoral neck mean BMD < 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

. 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
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;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.