Bone and body composition response to testosterone therapy vary according to polymorphisms in the CYP19A1 gene

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ORIGINAL ARTICLE

Bone and body composition response to testosterone therapy vary according to polymorphisms in the CYP19A1 gene Lina E. Aguirre1,2 Georgia Colleluori3,4 David Robbins1,2 Richard Dorin1,2 Vallabh O. Shah1,2 Rui Chen Irum Zeb Jan1 Clifford Qualls1,2,5 Dennis T. Villareal3,4 Reina Armamento-Villareal3,4 ●













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Received: 19 May 2019 / Accepted: 6 July 2019 © Springer Science+Business Media, LLC, part of Springer Nature 2019

Abstract Purpose To evaluate the influence of single nucleotide polymorphisms (SNPs) of CYP19A1 on the response and susceptibility to side effects from testosterone therapy. This is a prospective, single-arm study of men with low-morning serum testosterone (132.63 µmol/L), history of prostate and breast cancer, untreated sleep apnea, and conditions that may prevent the subject from finishing the study. The study was monitored by the Veterans Affairs Clinical Science Research and Development Data Monitoring Committee, which convened three times a year.

Testosterone therapy

This is a single arm, open label clinical trial in men with low-serum testosterone (52%. Repeat testosterone measurement was performed 2 months after a dose change, including a repeat hematocrit for those with elevated hematocrit. Otherwise, testosterone levels were measured at baseline, 3, 6, 12, and 18 months. Safety monitoring included assessment of prostate specific antigen (PSA), hematocrit, lipid profile, and liver enzymes at baseline, 3, 6, 12, and 18 months.

Study population

Body mass index

A total of 342 male veterans attending the Endocrine, Urology and Primary Care Clinics of the NMVAHCS and MEDVAMC were screened for the study. Inclusion criteria: males, 40–75-years-old, and with average morning fasting total serum testosterone of