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
- Conditions
- Delayed and non-united fractures in osteoporotic patientsMedDRA version: 12.1Level: LLTClassification code 10031283Term: Osteoporosis fracture
- Registration Number
- EUCTR2009-017039-16-FR
- 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
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 withNon-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 prio 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
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,<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>
- Secondary Outcome Measures
Name Time Method