Conditions: Osteoporosis Osteopenia
Keywords: Osteoporosis Osteopenia AMG 162 Fracture - hip Postmenopausal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1189
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.

Detailed description:

Arms:
arm 1: Subjects in this arm will receive active ALN and placebo denosumab arm 2: Subjects in this arm will receive active denosumab and placbo ALN

Interventions: intervention 1: Alendronate intervention 2: Denosumab
Intervention descriptions: intervention 1: ALN; 70 mg; oral; once weekly intervention 2: 60 mg; SC; every 6 months

Protocol document: