Efficacy of strontium ranelate in the management of long bone fractures
- Conditions
- Delayed and non-united fracturesMedDRA version: 14.1Level: PTClassification code 10017088Term: Fracture nonunionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 14.1Level: PTClassification code 10017081Term: Fracture delayed unionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2009-017039-16-CZ
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Men aged 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
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 with delayed union or non-union.;Secondary Objective: Not applicable;Primary end point(s): Radiological state at the fractured site asessessed by radiography,<br>Time to progression,<br>Algofunctional behaviour of the affected limb,<br>Pain intensity using a Visual Analogue Scale of 10 cm,<br>Full recovery to walk and improvement to walk,<br>Secondary surgical interventions,<br>Quality of Life,<br>Improvement in mobility,<br>Safety.<br>;Timepoint(s) of evaluation of this end point: 1. Radiological union of the fracture, performed every 2 or 3 months during the study<br>2. Clinical assessments (including pain, quality of life, mobility, etc.), performed performed every 2 or 3 months during the study (mobility test performed every 6 months)<br>3. Safety evaluations, performed every 2 or 3 months during the study <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): No secondary outcome measures ;Timepoint(s) of evaluation of this end point: Not applicable