A 3 year, double-blind extension to CZOL446H2301 to evaluate the long term safety and efficacy of zoledronic acid in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D

Update Il y a 4 ans
Reference: EUCTR2005-000668-17

Woman Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

To assess the percent change in BMD of the femoral neck as measured by DXA at Year 6 relative to Year 3 in patients treated with zoledronic acid for up to 6 years in the CZOL446H2301 core and extension studies (Group Z6) compared to patients treated with zoledronic acid for 3 years in the CZOL446H2301 core study followed by up to 3 years of placebo in the CZOL446H2301 extension study (Group Z3P3).


Inclusion criteria

  • Osteoporosis in postmenopausal women