A double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
| ISRCTN | ISRCTN50493318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50493318 |
| Clinical Trials Information System (CTIS) | 2006-005581-39 |
| Protocol serial number | CL3-12911-025 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 04/06/2007
- Registration date
- 12/07/2007
- Last edited
- 20/04/2020
- 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 Pierre D. Delmas
Scientific
Scientific
INSERM Unité 831
Service de Rhumatologie et de Pathologie Osseuse Pavillon F
Hôpital E. Herriot
Lyon
69437
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind double-dummy randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis |
| Study objectives | To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with biphosphonates on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for one year. |
| Ethics approval(s) | First Ethics Committee approval obtained on 01/03/2007 in Milan, Italy (ref: 148) |
| Health condition(s) or problem(s) studied | Postmenopausal osteoporosis in women |
| Intervention | Intervention group: 2 g (one sachet) orally per day of strontium ranelate and one capsule of placebo for 6 or 12 months Control group: one capsule of bisphosphonates and one sachet of placebo for 6 or 12 months |
| Intervention type | Other |
| Primary outcome measure(s) |
Histomorphometry on paired transiliac biopsies performed at baseline and after treatment (cancellous mineralising surfaces). |
| Key secondary outcome measure(s) |
1. Other histomorphometric parameters |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 285 |
| Total final enrolment | 387 |
| Key inclusion criteria | 1. Women of at least 50 years of age 2. Postmenopausal for at least three years 3. Osteoporosis |
| Key exclusion criteria | 1. Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side 2. Previous and concomitant treatments interfering with bone metabolism |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- United Kingdom
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Czech Republic
- Denmark
- Estonia
- France
- Hungary
- Italy
- Mexico
- Poland
Study participating centre
INSERM Unité 831
Lyon
69437
France
69437
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | 20/04/2020 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/04/2020: 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.
04/12/2017: results summary added.
