Conditions: Osteoporosis, Postmenopausal
Keywords: denosumab Republic of Korea dual energy x-ray absorptiometry
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.

Detailed description:

Arms:
arm 1: denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase arm 2: placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase arm 3: open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase

Interventions: intervention 1: denosumab intervention 2: placebo intervention 3: open-label denosumab
Intervention descriptions: intervention 1: double-blind phase: 60mg subcutaneous injection, single dose intervention 2: double-blind phase: placebo subcutaneous injection, single dose intervention 3: open-label phase: 60mg subcutaneous injection, single dose

Protocol document: