Influence of subject discontinuation on long-term nonvertebral fracture rate in the denosumab FREEDOM Extension study.

ABSTRACT:

Background

Denosumab treatment for up to 8 years in the FREEDOM study and Extension was associated with low fracture incidence. It was not clear whether subjects who discontinued during the study conduct had a higher risk of fracture than those who remained enrolled, thereby underestimating the true fracture risk for the entire trial cohort. Thus, we explored the influence of early withdrawals on nonvertebral fracture incidence during the Extension study.

Methods

To understand the potential effect of depletion of susceptible subjects on fracture incidence, we first evaluated subject characteristics in patients who were enrolled in the Extension vs those who were not. We subsequently employed a Kaplan-Meier multiple imputation (KMMI) approach to consider subjects who disconti

SUBMITTER: Adachi JD 

PROVIDER: S-EPMC5408481 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature