Efficacy of strontium ranelate in the management of long bone fractures in osteoporotic patients
| ISRCTN | ISRCTN60251236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60251236 |
| EudraCT/CTIS number | 2009-017039-16 |
| Secondary identifying numbers | CL3-12911-036 |
- Submission date
- 21/06/2010
- Registration date
- 09/07/2010
- Last edited
- 21/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Jean-Marc Feron
Scientific
Scientific
Hôpital Saint Antoine
Service dorthopédie et de traumatologie
184 rue du Faubourg St Antoine
Paris Cedex 12
F 75571
France
Study information
| Study design | Open labelled treatment period of 12 months |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Lower long bone fracture |
| Intervention | One sachet of strontium ranelate (2 g per day) during 12 months. |
| Intervention type | Other |
| 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 study start date | 15/06/2010 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 48 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/06/2010 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- Brazil
- Czech Republic
- France
- Hungary
- Italy
- Portugal
- Romania
Study participating centre
Hôpital Saint Antoine
Paris Cedex 12
F 75571
France
F 75571
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Abstract results | abstract from ACR/ARHP Annual Meeting | 05/10/2013 | No | No | |
| Basic results | 21/04/2020 | No | No |
Editorial Notes
21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
20/12/2017: internal review.
11/12/2017: results summary and abstract reference added.
