Femme Homme
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Extrait
The primary objectives of this study are to evaluate 1. whether the efficacy of denosumab (60 mg subcutaneously every 6 months) manufactured by the proposed process referred to as CP4 is not inferior to that of denosumab manufactured by the currently approved commercial process referred to as CP2 based on the change in lumbar spine bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) at 12 months in postmenopausal women with osteoporosis; 2. whether the efficacy of denosumab CP4 (60 mg subcutaneously every 6 months) is equivalent to that of denosumab CP2 based on the change in lumbar spine BMD by DXA at 12 months in postmenopausal women with osteoporosis.
Critère d'inclusion
- Post Menospausal Osteoporosis