Additional identifiers
EudraCT number
2009-017039-16
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-036
Study information
Scientific title
Effect of strontium ranelate (2 g per day) in the management of long bone fractures with delayed-union or non union: an international open label study in patients with osteoporosis
Acronym
Study hypothesis
Current study hypothesis as of 30/11/2012:
To assess the effects of strontium ranelate 2 g/day in the management of aseptic fractures of long bones with delayed union or non-union
As of 27/07/11:
To assess the effects of strontium ranelate 2 g/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.
Please note that as of 30/11/2012, the following changes were made to the record:
1. The anticipated end date was updated from 31/12/2011 to 30/04/2013
2. France and Germany were removed from the countries of recruitment, and Romania was added
3. The public title was previously "Efficacy of strontium ranelate in the management of limb fractures in osteoporotic patients"
4. The scientific title was previously "Effect of strontium ranelate (2 g per day) in the management of limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis"
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Open labelled treatment period of 12 months
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lower long bone fracture
Intervention
One sachet of strontium ranelate (2 g per day) during 12 months.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
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
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/06/2010
Overall trial end date
30/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
30/11/2012: Current inclusion criteria as of 01/09/2011:
1. Men aged > 18 years and postmenopausal women menopause >2 years
2. Patient with long bone fracture with a delayed union or a non-union
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Fractures not meeting inclusion criteria (including pathological fractures)
2. Bone-related disease other than osteoporosis
3. Concomittant treatments interfering with bone metabolism
Recruitment start date
15/06/2010
Recruitment end date
30/04/2013
Locations
Countries of recruitment
Brazil, Czech Republic, Hungary, Italy, Portugal, Romania
Trial participating centre
Hôpital Saint Antoine
Paris Cedex 12
F 75571
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published on https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-036_synopsis_report.pdf
Publication list
2013 abstract from ACR/ARHP Annual Meeting on: http://acrabstracts.org/abstract/efficacy-of-a-6-month-treatment-with-strontium-ranelate-2gday-in-the-improvement-of-long-bone-fractures-with-delayed-union-or-non-union/