EUCTR2009-017039-16-FRActive, not recruitingPhase 1
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
Institut de Recherches Internationales Servier0 sites40 target enrollmentStarted: April 2, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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
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.
Investigators
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