Conditions: Osteoporosis, Postmenopausal
Keywords: India dual energy x-ray absorptiometry bone mineral density denosumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
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 Indian postmenopausal women with osteoporosis.

Detailed description:

Arms:
arm 1: denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind treatment arm 2: placebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment

Interventions: intervention 1: denosumab intervention 2: placebo
Intervention descriptions: intervention 1: 60mg subcutaneous injection, single dose intervention 2: placebo subcutaneous injection, single dose

Protocol document: