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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020215-36-DE
Enrollment
126
Registered
2011-01-27
Start date
2011-05-03
Completion date
Unknown
Last updated
2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of periprosthetic bone loss in patients with total hip arthoplasty for coxarthrosis MedDRA version: 14.1 Level: PT Classification code 10052306 Term: Periprosthetic osteolysis System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: PROTELOS Product Name: S12911 Product Code: S12911 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: strontium ranelate CAS Number: 135459-90-4 Current Sponsor code: S

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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? 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

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®.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Germany, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026