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ISRCTN
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ISRCTN60251236
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ClinicalTrials.gov identifier
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Public title
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Efficacy of strontium ranelate in the management of limb fractures in osteoporotic patients
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Scientific title
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Effect of strontium ranelate (2g per day) in the management of limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis
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Acronym
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N/A
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Serial number at source
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CL3-12911-036
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Study hypothesis
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As of 27/07/11:
To assess the effects of strontium ranelate 2g/day in the management of aseptic fractures of limbs with delayed union or non-union
As of 09/07/10:
To assess the effects of strontium ranelate 2 g/day in the management of aseptic fractures of the lower limbs with delayed union or non-union.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethic approval was obtained before recruitment of the first participants.
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Study design
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Open labelled treatment period of 12 months
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Countries of recruitment
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Brazil, Czech Republic, France, Germany, Hungary, Italy, Portugal
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Disease/condition/study domain
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Lower limb fracture, osteoporosis
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Participants - inclusion criteria
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As of 27/07/11:
1. Osteoporotic men and osteoporotic postmenopausal women.
2. Patient with a fracture of limb with a delayed union or a non-union
As of 09/07/10:
1. Osteoporotic men and osteoporotic postmenopausal women
2. Patient with a fracture of the lower limbs with a delayed union or a non-union
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Participants - exclusion criteria
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1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Bone-related disease other than osteoporosis
3. Concomittant treatments interfering with bone metabolism
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Anticipated start date
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15/06/2010
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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One sachet of strontium ranelate (2 g per day) during 12 months.
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Primary outcome measure(s)
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1. Radiological union of the fracture, performed every 2 or 3 months during the study
2. Clinical assessments (including pain, quality of life, mobility, etc.), performed every 2 or 3 months during the study (mobility test performed every 6 months)
3. Safety evaluations, performed every 2 or 3 months during the study
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Institut de Recherches Internationales Servier (France)
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Trial website
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Publications
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Contact name
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Prof
Jean-Marc
Feron
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Address
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Hôpital Saint Antoine
Service d’orthopédie et de traumatologie
184 rue du Faubourg St Antoine
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City/town
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Paris Cedex 12
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Zip/Postcode
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F 75571
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Country
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France
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Sponsor
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Institut de Recherches Internationales Servier (France)
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Address
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6, place des Pleiades
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City/town
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Courbevoie
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Zip/Postcode
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92415
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Country
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France
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Date applied
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21/06/2010
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Last edited
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27/07/2011
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Date ISRCTN assigned
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09/07/2010
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