The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension.

ABSTRACT:

Context

The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years.

Objective

The objective of the study was to report results from the first 3 years of the extension, representing up to 6 years of denosumab exposure.

Design, setting, and participants

This was a multicenter, international, open-label study of 4550 women.

Intervention

Women from the FREEDOM denosumab group received 3 more years of denosumab for a total of 6 years (long-term) and women from the FREEDOM placebo group received 3 years of denosumab (crossover).

Main outcome measures

Bone turnover markers (BTMs), bone mineral density (BMD), fracture, and safety data are report

SUBMITTER: Bone HG 

PROVIDER: S-EPMC4207950 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature