Mobile

First Extension (018-06(PL_3)): A Blinded Extension to 5 Years for: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Ri...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002693-66

First Extension (018-06(PL_3)): A Blinded Extension to 5 Years for: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium Second Extension (018-20(PL_1)): A 2nd Open-Label Extension for 5 Years to: The Placebo-Controlled 1st Extension to a Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium Second Extension (018-21(PL_2)): An Open-Label 5-Year 2nd Extension to: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

Femme Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

First Extension To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. To assess the effect of treatment up to 5 years with odanacatib on the risk of clinical hip fractures compared to placebo. To assess the effect of treatment up to 5 years with odanacatib on the risk of non-vertebral clinical fractures compared to placebo. To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo. Second extension: To assess long-term changes from baseline in total hip BMD during 10 years of treatment with odanacatib 50 mg once-weekly in postmenopausal osteoporotic women previously treated with once-weekly odanacatib for at least 5 years (cumulative of base study and 1st extension study, i.e randomized to odanacatib during the base study To assess safety and tolerability of long-term treatment with odanacatib 50 mg once-weekly.

Critère d'inclusion

  • Postmenopausal osteoporosis

Liens