WHO ICTRP trial
The efficacy and safety of a daily oral administration of S06911 (strontium…
EUCTR2009-013935-39-FI · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2009-013935-39-FI |
|---|---|
| Public 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. |
| 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… |
| Primary sponsor | Institut de Recherches Internationales Servier |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;Hungary;Czech Republic;Slovakia;Finland;Poland;Belgium;Spain;Austria;Denmark;Germany;United Kingdom |
| Conditions | Osteoporotic men and postmenauposal women MedDRA version: 12.0 Level: LLT Classification code 10031283 Term: Osteoporosis fracture MedDRA version: 12.0 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal |
| Interventions | Product Name: S06911 Product Code: S06911 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: strontium ranelate CAS Number: 135459-90-4 Current Sponsor code: S12911 Concentration unit: g gram(s) Concentration type: equal… |
| Registration date | Oct 26, 2009 |
| Target size | 500 |
| Secondary IDs | CL3-06911-002 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: