Effects of long-acting testosterone undecanoate on bone mineral density in middle-aged men with late-onset hypogonadism and metabolic syndrome: results from a 36 months controlled study

Abstract

We evaluated the effects of long-term testosterone replacement therapy (TRT) on the bone mineral density (BMD) in obese patients with metabolic syndrome (MS) and late-onset hypogonadism (LOH). Sixty men (mean age 57 ± 10) with low serum testosterone (T < 320 ng/dL) and MS regardless the presence of osteoporosis were enrolled. Forty men received intramuscular T-undecanoate (TU) four times/year for 36 months and 20 age-matched hypogonadal men with MS in whom T treatment was contraindicated were used as controls. Hormonal, biochemical markers, vertebral and femoral BMD by dual-energy x-ray absorptiometry were measured. At baseline, overall patients had mild osteopenia (lumbar BMD= 0.891 ± 0.097 g/cm(2); femoral BMD= 0.847 ± 0.117 g/cm(2)). TU induced a significant improvement of bone mass after 36 months (lumbar BMD=1.053 ± 0.145 g/cm(2); p < 0.002; femoral BMD=0.989 ± 0.109; p < 0.003 g/cm(2)) with a 5%/year increase and a significant reduction in hs-CRP without changes in body mass index. A direct relationship between serum T and BMD increments at the lumbar (r(2) = 0.66, p < 0.0001) and femoral (r(2) =0.52, p < 0.0001) sites was demonstrated. Study adherence was 50% without serious side effects. Long-term TRT in middle-aged men with LOH and MS determines a significant increase in both vertebral and femoral BMD related to increased serum T levels, probably independently from estradiol modifications.

Testosterone Therapy and Cardiovascular Risk: Advances and Controversies

“…[28][29][30][31] Promising new data reveal that T therapy improves insulin sensitivity [32][33][34] and reduces blood glucose 23,25,35 and hemoglobin A 1c (HbA 1c ) 23,25,27,35 levels in men with type 2 diabetes or obesity.…”

The assessment of testosterone and radioisotopic index of bone metabolism and bone mineral density in men with testosterone deficiency after one year of testosterone therapy

“…Late hypogonadism occurs over the age of 60 yrs. The reduction in testosterone levels with age exacerbates muscle weakness and muscle mass loss and leads to osteopenia and osteoporosis [12][13][14][15][16][17]. There are a number of methods assessing changes in bone system [18,19].…”

Recommendations on the diagnosis, treatment and monitoring of late-onset hypogonadism in men – a suggested update

“…Effects on depressive mood become detectable after 3 to 6 weeks of starting TRT, with maximum improvement occurring after 18 to 30 weeks. Improvements in bone are detectable after 6 months of TRT, while the full beneficial effect of TRT on bone mineral density may take 24 months [69] or 36 months as suggested by Aversa [70]. Effects of TRT on lipids appear after 4 weeks, with maximal effects being seen after 6 to 12 months of treatment.…”