Effects of Testosterone Replacement in Hypogonadal Heart Transplanted Men

Author(s): Doris Wagner, Karin Amrein, Julia Mader, Oliver Malle, Astrid Fahrleitner-Pammer

Context: Hypogonadism is common in cardiac transplant patients and exerts negative effects on bone, but also libido and quality of life.

Objective: We investigated whether testosterone replacement therapy (TRT) on top of ibandronate in hypogonadal CTX recipients is beneficial for important clinical outcomes.

Design: Observational study (eugonadal and hypogonadal) and non-blinded randomized controlled trial (hypogonadal subgroup).

Setting: Academic tertiary care center at the Medical University of Graz, Austria

Patients: 52 heart transplanted men (21 eugonadal, 31 hypogonadal) with untreated osteoporosis (median 50 months post transplantation). 8 patients could not enter the study because of pathological urologic examination.

Intervention(s): Besides standard therapy with ibandronate 2 mg quarterly iv and oral daily calcium/vitamin D, hypogonadal men were randomly assigned to either testosterone replacement (n=14) or not (n=17).

Main Outcome Measures: Bone mineral density (BMD), fracture incidence, sexual function

Results: At baseline, hypogonadal compared to eugonadal men had lower Z-score values at the femoral neck (-1.54 vs. 0.15) and total hip (-1.34 vs. 0.01) (all P<0.001) and significantly more prevalent vertebral fractures (63% vs. 14%, P<0.001). After 5 years, BMD increased in all patients, however, hypogonadal patients with additional TRT showed a higher increase and fracture incidence was significantly lower in patients receiving additional TRT (21% compared to 41%; p= 0.001). Patients on TRT also reported an increase in sexual activities after 1 (29 ± 8; p<0.001) and 5 years (25 ± 9; p<0.001), while no changes were reported by the other groups.