Effect of strontium ranelate in the management of long bone fractures.

• Conditions: Delayed and non-united fractures; MedDRA version: 14.1Level: PTClassification code 10017088Term: Fracture nonunionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: PTClassification code 10017081Term: Fracture delayed unionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2009-017039-16-HU
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-24
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Men aged at least 18 years and postmenopausal women with a fracture of the limb or clavicle with delayed union, defined as an absence of radiological full union after 6 months according to investigator's opinion
OR with Non-union defined as non-union for at least 6 months and no sign of radiological healing or bone reaction since at least 3 months,
Ambulatory prior to the qualifying 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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13
;
Men aged at least 18 years and postmenopausal women with a fracture of the limb or clavicle with delayed union, defined as an absence of radiological full union after 6 months according to investigator's opinion
OR with Non-union defined as non-union for at least 6 months and no sign of radiological healing or bone reaction since at least 3 months,
Ambulatory prior to the qualifying 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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

­Not pathological fracture,
Bone-related disease other than osteoporosis,
Septic or synovial or congenital pseudarthrosis,
Fracture with a fracture gap, after reduction or treatment, greater than more the half the width of the affected bone,
Concomitant treatments interfering with bone metabolism,
History of venous thrombo-embolism,
History of intolerance, allergy or hypersensitivity to strontium ranelate,
Contraindication to Calperos D3.
;
­Not pathological fracture,
Bone-related disease other than osteoporosis,
Septic or synovial or congenital pseudarthrosis,
Fracture with a fracture gap, after reduction or treatment, greater than more the half the width of the affected bone,
Concomitant treatments interfering with bone metabolism,
History of venous thrombo-embolism,
History of intolerance, allergy or hypersensitivity to strontium ranelate,
Contraindication to Calperos D3.

Study & Design

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