Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension.

ABSTRACT:

Purpose

The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study.

Materials and methods

Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg.

Results

Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2%

SUBMITTER: Koh JM 

PROVIDER: S-EPMC4951467 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature