Endocrine Abstracts

Aims: Both functional hypogonadism (FH) and type 2 diabetes (T2D) negatively affect bone mineral density (BMD). We aimed to evaluate changes on bone turnover markers (BTMs) and BMD in obese males with FH and T2D due to testosterone therapy (TTh).

Research Design and Methods: 55 obese males with FH and T2D participated in a two-year (first year double-blind, placebo-controlled study, second year follow-up) clinical trial. Participants were randomized into two groups. Group T (n=28) received 1000 mg testosterone undecanoate (TU) both years of the study while group P (n=27) received placebo first year and TU second year. BTMs C-telopeptide of type I collagen (CTX) and procollagen I N-terminal propeptide (PINP), estradiol, 25-hydroxyvitamin D, total, calculated free and calculated bioavailable testosterone levels were assessed at baseline, 12 and 24 months. BMD changes were evaluated at baseline and after 24 months using dual-energy x-ray absorptiometry (DXA).

Results: Results show decrease in median CTX from baseline of 1055 (676 to 1344) pmol/l to 911 (556 to 1152) pmol/l after one year of placebo (P=.012), then to 453 (365 to 665) pmol/l after one year of TTh (P<.001) in group P and from 887 (648 to 1496) pmol/l to 504 (262 to 804) pmol/l after first year of TTh (P<.001), then to 372 (165 to 599) after second year of TRT (P<.001) in group T. Median PINP did not change from 31.4 (27.1 to 40.3) μg/l baseline at statistically significant level after one year of placebo (P=.469) in group Pbut decreased to 28.0 (23.6 to 32.0) μg/l after one year of TTh (P=.009); in group T a decrease from 30.9 (21.9 to 35.3) μg/l to 26.2 (18.6 to 32.1) μg/l was observed after first year of TTh (P=.005), then to 20.1 (17.8 to 26.5) μg/l after second year of TRT (P<.001). DXA showed no changes in femoral neck BMD in 32 patients from both groups P (n=16) or T (n=16) while a statistically significant increase in lumbar spine BMD by.075 ±.114 g/cm² (95% CI:.014 to.136; P=.019) has been observed in group T following two years of TTh.

Conclsions: BTMs decreased significantly after TU and improvement of lumbar spine BMD was observed after two years of TTh in obese males with FH and T2D.