A prospective, controlled, double blind, international study to assess the effects of strontium ranelate vs. placebo on the reduction of periprosthetic bone loss in patients with total hip arthroplasty. The ''Periprosthetic bone loss'' study - The ''Periprosthetic bone loss'' study

• Conditions: Reduction of periprosthetic bone loss in patients with total hip arthoplasty for coxarthrosis; MedDRA version: 14.0Level: PTClassification code 10052306Term: Periprosthetic osteolysisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-020215-36-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-02
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Caucasian men or postmenopausal women, Age = 50 years, Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication of total hip arthroplasty.
Are the trial subjects under 18?
Number of subjects for this age range: 0
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

­Short femoral stem, -­Any perioperative complication, -­Patients with inflammatory arthropathy, -Impossibility to perform DXA, -Increased risk or history of VTE, -Known hypersensitivity or contraindication to the study drug or Calperos D3.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show the efficacy of strontium ranelate versus placebo in the reduction of periprosthetic bone loss in region 7 of Gruen, over 12 months of treatment after total hip arthroplasty.;Secondary Objective: To show the efficacy of strontium ranelate versus placebo in the reduction of periprosthetic bone loss in proximal and total regions of interest and in region 1 to 6 of Gruen, over 12 months of treatment. To assess the efficacy of strontium ranelate versus placebo on the same criteria described above over 6 months of treatment. To assess the safety of strontium ranelate over 12 months of treatment.;Primary end point(s): The relative change of periprosthetic BMD in region 7 of Gruen from baseline to last post baseline value over 12 months of treatment after total hip arthroplasty.