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

Femme Homme

| Pays :
| Organes :
| Spécialités :

Extrait

Objectives 1st extension: 1. To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. 2. To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo. Obejctives 2nd extension: In postmenopausal women with osteoporosis randomized to odanacatib 50 mg once-weekly in the base study and continuing on odanacatib during base and both extension periods: To assess change from baseline in total hip BMD after 10 years of treatment. To assess safety and tolerability of long-term treatment

Critère d'inclusion

Postmenopausal osteoporosis

Liens

ictrp
euctr

Kusajili – Centralise les essais cliniques mondiaux

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 t...