Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis - ND

• Conditions: Delayed and non-united fractures in osteoporotic patients; MedDRA version: 12.1Level: LLTClassification code 10031283Term: Osteoporosis fracture

• Registration Number: EUCTR2009-017039-16-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-26
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

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

Inclusion Criteria

- Osteoporotic patients, - With a fracture of the lower limbs 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

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 in the management of aseptic fractures of the lower limbs with delayed union or non-union.;Secondary Objective: ;Primary end point(s): Radiological state at the fractured site asessessed by radiography, - Time to progression, - Algofunctional behaviour of the affected limb, - Pain intensity using a Visual Analogue Scale of 10 cm, - Full recovery to walk and improvement to walk, - Secondary surgical interventions, - Quality of Life, - Improvement in mobility.