Conditions: Post Menopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 643
Healthy volunteers: no

Brief summary:
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

Detailed description:

Arms:
arm 1: Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1. arm 2: Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.

Interventions: intervention 1: Denosumab intervention 2: Zoledronic Acid intervention 3: Placebo to Denosumab intervention 4: Placebo to Zoledronic Acid
Intervention descriptions: intervention 1: Denosumab 60 mg administered by subcutaneous injection once every 6 months. intervention 2: Zoledronic acid 5 mg administered by intravenous infusion once a year intervention 3: Administered by subcutaneous injection once every 6 months intervention 4: Administered by intravenous infusion once a year

Protocol document: