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A 2-year randomized, multicenter, double-blind, placebocontrolled study to determine the efficacy and safety of intravenous zoledronic acid 5 mg administered either annually at randomization and 12 mo...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-000638-35

A 2-year randomized, multicenter, double-blind, placebocontrolled study to determine the efficacy and safety of intravenous zoledronic acid 5 mg administered either annually at randomization and 12 months, or administered at randomization only in the prevention of bone loss in postmenopausal women with osteopenia

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Extrait

- To demonstrate that zoledronic acid 5 mg i.v. given annually at randomization and Month 12 is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I (women < 5 years from menopause) and in Stratum II (women ≥ 5 years from menopause) - To demonstrate that zoledronic acid 5 mg i.v. given at randomization only is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I and in Stratum II

Critère d'inclusion

  • Postmenopausal osteoporosis

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