Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab
Status:
Terminated
Trial end date:
2020-06-10
Target enrollment:
Participant gender:
Summary
The goal of the study is to characterize the effect of Prolia® (denosumab) on indices of bone
strength in type 2 diabetes (T2D). The investigational plan involves administration of
Prolia® or identical placebo for 12 months as a randomized double-blind placebo-controlled
trial in 66 T2D postmenopausal women assigned to Prolia® or placebo. The study will include
assessment of different measures of bone quality: skeletal microarchitecture, including
measurement of skeletal cortical pores; bone mineral density; bone material quality, and
accumulation of advanced glycation endproducts (AGEs) in collagen. This information will help
to determine whether Prolia® treatment in type 2 diabetes has skeletal benefits.