Efficacy and safety of S6911 on vitamin D insufficiency in OP patients

• Research type

  Research Study

• Full title

  The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000IU 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 sub-group of patients to assess safety of a daily oral administration of S06911.

• IRAS ID

  34536

• Contact name

  Cyrus Cooper

• Sponsor organisation

  Servier Research and Development Limited

• Eudract number

  2009-013935-39

• Research summary

  Strontium ranelate is a treatment for patients with postmenopausal osteoporosis to reduce the risk of vertebral and hip fracture. Vitamin D is prescribed as an additional treatment for osteoporosis and as a preventative measure, where the risk of vitamin D insufficiency has been identified. S06911 is a fixed combination of strontium ranelate and vitamin D. S06911 is intended as a daily treatment. The proposed indication is:Ó?treatment of osteoporosis in men and postmenopausal women who are not receiving vitamin D supplementation and are at risk of vitamin D insufficiency'. S06911 reduces the risk of vertebral and hip fractures. Published data from the FIRST clinical study suggests that European and Australian osteoporotic patients (age 50 and over) have a mean serum vitamin D concentration of about 41nm. To date patients are considered to be 'deficient' if their vitamin D levels are less that 22.5nmol/L; 'insufficient' if their levels are between 22.5 - 50 nmol/L; and 'inadequate' if levels are between 50-75nmol/L. The optimal concentration of vitamin D is considered to be at least 75nmol/L. Patients will be considered suitable for this study if their vitamin D levels are between 22.5 and 75nmol/L and they are osteoporotic (assessed by measuring their bone density). The main aim of this study is to demonstrate that a daily 1 sachet dose of S06911 (strontium ranelate vitamin D, taken as a mixture with water) will improve patients' vitamin D insufficiency. The study will also assess the safety and tolerability of S06911 (in comparison to strontium ranelate taken alone) over the 6 month period of the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/142

• Date of REC Opinion

  4 Feb 2010

• REC opinion

  Further Information Favourable Opinion