An international study to assess the effects of strontium ranelate in the reduction of bone loss around the metal implant, in patients with hip prosthesis
| ISRCTN | ISRCTN15928978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15928978 |
| EudraCT/CTIS number | 2010-020215-36 |
| Secondary identifying numbers | CL3-12911-037 |
- Submission date
- 31/05/2011
- Registration date
- 04/08/2011
- 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 Luisa Brandi
Scientific
Scientific
AOUC-D.A.I Ortopedia S.O.D
Malattie del Metabolismo Minerale ed Osseo CTO
Azienda Ospedaliero
Universitaria CareggiLargo Pelagi 1
Firenze
50139
Italy
Study information
| Study design | Prospective placebo-controlled randomised double-blind 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 prospective, controlled, double blind, international study to assess the effects of strontium ranelate vs placebo on the reduction of periprosthetic bone loss in patients with total hip arthroplasty |
| Study objectives | To demonstrate the efficacy of strontium ranelate in the reduction of bone loss in patients with total hip arthroplasty |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Periprosthetic bone loss / total hip arthroplasty |
| Intervention | Intervention (63 paticipants) - One sachet of 2g of strontium ranelate daily Placebo (63 paticipants) Total duration of intervention is 12 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure | The relative change of periprosthetic bone mineral density (BMD) in region 7 of Gruen after total hip arthroplasty over 12 months |
| Secondary outcome measures | 1. The relative change of other regions of Gruen over 12 months 2. Safety over 12 months |
| Overall study start date | 01/05/2011 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 126 |
| Total final enrolment | 96 |
| Key inclusion criteria | 1. Caucasian male or postmenopausal women 2. Age less than or equal to 50 years 3. Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication for total hip arthroplasty |
| Key exclusion criteria | 1. Short femoral stem 2. Any perioperative complication 3. Patient with inflammatory arthropathy 4. Impossibility to perform Dual-emission X-ray absorptiometry (DXA) 5. Increase risk or history of venous thromboembolism (VTE) 6. Known hypersensitivity or contraindication to the study drug or Calperos D3® 7. Concomittant treatments likely to interfere with bone metabolism |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- Belgium
- Brazil
- Germany
- Italy
- Spain
Study participating centre
AOUC-D.A.I Ortopedia S.O.D
Firenze
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.
