Publication Date
3-1-2021
Journal
Contemporary Clinical Trials Communications
DOI
10.1016/j.conctc.2021.100723
PMID
33718653
PMCID
PMC7933702
PubMedCentral® Posted Date
1-20-2021
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Keywords
Testosterone, Bone microarchitecture, Type 2 diabetes mellitus, Hypogonadism
Abstract
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 (μFEA) 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.
Included in
Biochemical Phenomena, Metabolism, and Nutrition Commons, Biochemistry, Biophysics, and Structural Biology Commons, Endocrine System Diseases Commons, Endocrinology, Diabetes, and Metabolism Commons