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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2016

At a glance

  • Drugs Colecalciferol/strontium-ranelate (Primary) ; Strontium ranelate
  • Indications Osteoporosis; Vitamin D deficiency
  • Focus Therapeutic Use
  • Sponsors Servier
  • Most Recent Events

    • 23 Jun 2012 Official title amended as reported by European Clinical Trials Database.
    • 29 Jul 2011 Actual end date (22 Jul 2011) added as reported by ISRCTN: Current Controlled Trials.
    • 29 Jul 2011 Status changed from recruiting to completed as reported by ISRCTN: Current Controlled Trials.
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