Efficacy and safety of strontium ranelate/vitamin D3 combination on vitamin D insufficiency in the treatment of osteoporotic patient
| ISRCTN | ISRCTN59279012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59279012 |
| Clinical Trials Information System (CTIS) | 2009-013935-39 |
| Protocol serial number | CL3-06911-002 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 03/05/2010
- Registration date
- 28/05/2010
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 Rene Rizzoli
Scientific
Scientific
Hôpital Cantonal
Département de réhabilitation et gériatrie
Genève 14
1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind 2 parallel group trial followed by an open-labelled one treatment study |
| Secondary study design | 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 insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911. |
| Study objectives | To demonstrate the efficacy of S06911 on the correction of vitamin D insufficiency. Please note that as of 19/11/2012, Denmark was removed from the countries of recruitment. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Osteoporosis, vitamin D insufficiency |
| Intervention | First period: one sachet per day of strontium ranelate/vitamin D3 fixed combination versus strontium ranelate alone Second period: strontium ranelate/vitamin D3 fixed combination The total duration of treatment and the total duration of follow-up for our interventions is 6 or 12 months. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Evaluate the serum 25-OH vitamin D3 levels over 3 months of treatment |
| Key secondary outcome measure(s) |
1. Evaluate the serum 25-OH vitamin D3 levels after 6 months |
| Completion date | 22/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Osteoporotic men and osteoporotic post-menopausal women 2. Age superior or equal 50 years, either sex 3. Caucasian 4. 25-OH vitamin D3 serum concentration greater than 22.5 nmol/L |
| Key exclusion criteria | 1. Progressive major illness, uncontrolled active disease, skeletal disease 2. History or increased risk of deep venous thrombosis or pulmonary embolism 3. History of intolerance, allergy or severe hypersensitivity with study drugs |
| Date of first enrolment | 27/01/2010 |
| Date of final enrolment | 22/07/2011 |
Locations
Countries of recruitment
- United Kingdom
- Austria
- Belgium
- Czech Republic
- Finland
- France
- Germany
- Hungary
- Poland
- Russian Federation
- Slovakia
- Spain
- Switzerland
Study participating centre
Hôpital Cantonal
Genève 14
1211
Switzerland
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? |
|---|---|---|---|---|---|
| Results article | results | 04/02/2014 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
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.
06/12/2017: results summary and publication reference added.
