Femme Homme
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Extrait
The primary objective is to determine whether denosumab (formerly known as AMG 162) treatment can reduce the number of postmenopausal osteoporotic women (BMD T-score below -2.5) with new vertebral fractures as compared with control (placebo plus vitamin D and calcium) The primary safety objective is to characterize the safety and tolerability profile of denosumab in this population based on the adverse event incidence, changes in laboratory profiles, and immunogenicity to denosumab.
Critère d'inclusion
- Treatment of postmenopausal osteoporosis