Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

Summary

Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.

Timeline

Start

2019-10-01

Primary completion

2025-10-08

Completion

2025-10-08

Publications

• Background Russo V, Chen R, Armamento-Villareal R. Hypogonadism, Type-2 Diabetes Mellitus, and Bone Health: A Narrative Review. Front Endocrinol (Lausanne). 2021 Jan 18;11:607240. doi: 10.3389/fendo.2020.607240. eCollection 2020.
• Background Deepika F, Ballato E, Colleluori G, Aguirre L, Chen R, Qualls C, Villareal DT, Armamento-Villareal R. Baseline Testosterone Predicts Body Composition and Metabolic Response to Testosterone Therapy. Front Endocrinol (Lausanne). 2022 Jul 11;13:915309. doi: 10.3389/fendo.2022.915309. eCollection 2022.
• Background Bathina S, Armamento-Villareal R. The complex pathophysiology of bone fragility in obesity and type 2 diabetes mellitus: therapeutic targets to promote osteogenesis. Front Endocrinol (Lausanne). 2023 Jul 20;14:1168687. doi: 10.3389/fendo.2023.1168687. eCollection 2023.
• Background Deepika F, Bathina S, Armamento-Villareal R. Novel Adipokines and Their Role in Bone Metabolism: A Narrative Review. Biomedicines. 2023 Feb 20;11(2):644. doi: 10.3390/biomedicines11020644.
• Background Bathina S, Prado M, Fuenmayor Lopez V, Colleluori G, Aguirre L, Chen R, Villareal DT, Armamento-Villareal R. PRDM16 Enhances Osteoblastogenic RUNX2 via Canonical WNT10b/beta-CATENIN Pathway in Testosterone-Treated Hypogonadal Men. Biomolecules. 2025 Jan 8;15(1):79. doi: 10.3390/biom15010079.
• Background Chen R, Armamento-Villareal R. Obesity and Skeletal Fragility. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e466-e477. doi: 10.1210/clinem/dgad415.
• Results Russo V, Colleluori G, Chen R, Mediwala S, Qualls C, Liebschner M, Villareal DT, Armamento-Villareal R. Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol. Contemp Clin Trials Commun. 2021 Jan 20;21:100723. doi: 10.1016/j.conctc.2021.100723. eCollection 2021 Mar.
• Results Ballato E, Deepika FNU, Russo V, Fleires-Gutierrez A, Colleluori G, Fuenmayor V, Chen R, Villareal DT, Qualls C, Armamento-Villareal R. One-Year Mean A1c of > 7% is Associated with Poor Bone Microarchitecture and Strength in Men with Type 2 Diabetes Mellitus. Calcif Tissue Int. 2022 Sep;111(3):267-278. doi: 10.1007/s00223-022-00993-x. Epub 2022 Jun 4.
• Results Bathina S, Lopez VF, Prado M, Ballato E, Colleluori G, Tetlay M, Villareal DT, Mediwala S, Chen R, Qualls C, Armamento-Villareal R. Health implications of racial differences in serum growth differentiation factor levels among men with obesity. Physiol Rep. 2024 Dec;12(23):e70124. doi: 10.14814/phy2.70124.
• Results Ballato E, Deepika F, Prado M, Russo V, Fuenmayor V, Bathina S, Villareal DT, Qualls C, Armamento-Villareal R. Circulating osteogenic progenitors and osteoclast precursors are associated with long-term glycemic control, sex steroids, and visceral adipose tissue in men with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2022 Sep 12;13:936159. doi: 10.3389/fendo.2022.936159. eCollection 2022.

Drugs

Indications