Efficacy of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal women
| ISRCTN | ISRCTN51868986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51868986 |
| EudraCT/CTIS number | 2009-014271-41 |
| Secondary identifying numbers | CL3-12911-035 |
- Submission date
- 28/05/2010
- Registration date
- 05/07/2010
- 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 Maria Brandi
Scientific
Scientific
University of Florence
Department of Internal Medicine
Division of Rheumatology and Metabolic bone Disease
Viale Pieraccini, 18
Florence
50139
Italy
Study information
| Study design | Randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | A multicentre, prospective, randomised, double-blind, placebo-controlled, international study to assess the effects of 2 g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women |
| Study acronym | The Fracture healing study |
| Study objectives | To demonstrate the efficacy of strontium ranelate 2 g versus placebo in accelerating radiological healing of distal radius fractures. Please note that as of 27/11/2012, Belgium, Russian Federation and Ukraine were added to the countries of recruitment. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Radius fracture, Osteoporosis |
| Intervention | One daily administration of strontium ranelate 2 g or placebo during 24 weeks. There is no visit after the last intake at week-24. |
| Intervention type | Other |
| Primary outcome measure | Time to radiological healing. Radiological evaluation will be performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit. |
| Secondary outcome measures | 1. Other radiological evaluations, performed at baseline, at week 4, 6, 7, 8, 9, 10, 12, 14 and at the last study visit. No radiography will be performed once radiological healing is complete, except at the last study visit. 2. Clinical evaluation (including mobility, quality of life, etc), performed at least once every 4 weeks from baseline to week 18 and at the last study visit 3. Safety evaluation, performed at least once every 4 weeks from baseline to week 18 and at the last study visit |
| Overall study start date | 01/05/2010 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 217 |
| Key inclusion criteria | 1. Osteoporotic men and osteoporotic post-menopausal women 2. Aged superior or equal to 50 years 3. Patient with a fracture of the distal radius (Colles' fracture) |
| Key exclusion criteria | 1. Fractures not meeting inclusion criteria (including displaced radius fractures) 2. Concomitant treatments likely to interfere with bone metabolism |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- Belgium
- Brazil
- Czech Republic
- France
- Germany
- Hungary
- Italy
- Russian Federation
- Ukraine
- United Kingdom
Study participating centre
University of Florence
Florence
50139
Italy
50139
Italy
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 | |||
| 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.
11/12/2017: results summary added.
