Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol

Context: Type 2 diabetes mellitus (T2D) is often accompanied by male hypogonadism and both conditions are associated with increased risk for fractures. Testosterone (T) has been shown to improve the bone health of hypogonadal men but has not been tested in patients who also have T2D in addition to low T. To date, there is no treatment that is specifically recommended for bone disease among patients with T2D. This study will evaluate the effect of T therapy on the bone health of male veterans with low T who also have T2D. Methods: This is a randomized double-blind placebo-controlled trial of 166 male veterans 35-65 years old, with T2D and hypogonadism, randomized to either T gel 1.62% or placebo for 12 months. We will evaluate the effect of T therapy on the following primary outcomes:1) changes in bone strength as measured by microfinite elements analysis (mu FEA) using high-resolution peripheral quantitative computer tomography, 2) changes in bone turnover markers, and 3) changes in circulating osteoblast progenitors (COP) and osteoclast precursors cells. Discussion: We anticipate that T therapy will result in improvement in bone strength owing to improvement in bone remodeling through an increase in osteoblastic differentiation and proliferation in patients with hypogonadism and T2D.

Automated summary

This study aims to evaluate the impact of T therapy on bone health in male veterans with low T and T2D, focusing on changes in bone strength, bone turnover markers, circulating osteoblast progenitors (COP) and osteoclast precursors cells. We expect that T therapy will improve bone strength through enhancement of bone remodeling in patients with hypogonadism and T2D.