Efficacy and safety of strontium ranelate/vitamin D3 combination on vitamin D deficiency in the treatment of osteoporotic patient
| ISRCTN | ISRCTN47943635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47943635 |
| Clinical Trials Information System (CTIS) | 2009-014270-18 |
| Protocol serial number | CL3-06911-003 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 20/05/2010
- Registration date
- 15/06/2010
- Last edited
- 20/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Département de réhabilitation et gériatrie
Hôpital Cantonal
Genève 14
1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective open-labelled phase III study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D deficiency in the treatment of osteoporotic postmenopausal women and men. A 12 month, prospective, open labelled, one treatment group international phase III study. |
| Study objectives | To demonstrate the efficacy and the safety of S06911 in patients with vitamin D deficiency. Please note that as of 27/11/2012, the following changes were made to the record: 1. Denmark was removed from the countries of recruitment 2. The anticipated end date was updated from 27/07/2011 to 30/06/2011 |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Osteoporosis, vitamin D deficiency |
| Intervention | One sachet per day of strontium ranelate/vitamin D3 fixed combination during 12 months. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Evaluate the efficacy over 12 months of treatment on the correction of vitamin D insufficiency in patients with deficient vitamin D serum levels |
| Key secondary outcome measure(s) |
1. Evaluate the efficacy over 12 months of treatment on the correction of vitamin D deficiency |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Osteoporotic men and osteoporotic post-menopausal women 2. Age superior or equal 50 years 3. Caucasian 4. 25-OH vitamin D3 serum concentration inferior or equal to 22.5 nmol/L |
| Key exclusion criteria | 1. Progressive major illness 2. Uncontrolled active disease 3. Skeletal disease 4. History or increased risk of deep venous thrombosis or pulmonary embolism 5. History of intolerance, allergy or severe hypersensitivity with study drugs |
| Date of first enrolment | 27/01/2010 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Belgium
- Poland
- Russian Federation
- Slovakia
- Spain
- Switzerland
Study participating centre
1211
Switzerland
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 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.
18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
20/12/2017: results summary added.
