Conditions: Postmenopausal Osteoporosis
Keywords: RANKL RANK denosumab AMG 162 osteoporosis bone turnover bone mineral density clinical trial postmenopausal osteoporosis alendronate total hip bone mineral density
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 504
Healthy volunteers: no

Brief summary:
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: alendronate intervention 2: Denosumab (AMG 162)
Intervention descriptions: intervention 1: 70 mg oral QW intervention 2: 60 mg SC q 6 mos

Protocol document: