Conditions: Osteoporosis
Keywords: RANKL RANK denosumab AMG 162 osteoporosis bone turnover bone mineral density Japanese
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 212
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: 100 mg AMG 162 intervention 2: 60 mg AMG 162 intervention 3: 14 mg AMG 162 intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg AMG 162 (denosumab) SC every 6 months intervention 2: 60 mg AMG 162 (denosumab) SC every 6 months intervention 3: 14 mg AMG 162 (denosumab) SC every 6 months intervention 4: Placebo SC every 6 months

Protocol document: