title: 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.
authors.affiliation: Department of Experimental Medicine, Medical Pathophysiology, Food and Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy. antonio.aversa@uniroma1.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Aversa
authors.forename: Roberto
authors.initials: R
authors.lastname: Bruzziches
authors.forename: Davide
authors.initials: D
authors.lastname: Francomano
authors.forename: Emanuela A
authors.initials: EA
authors.lastname: Greco
authors.forename: Rachele
authors.initials: R
authors.lastname: Fornari
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Luigi
authors.forename: Andrea
authors.initials: A
authors.lastname: Lenzi
authors.forename: Silvia
authors.initials: S
authors.lastname: Migliaccio
mesh_terms: D000368:Aged; D000728:Androgens / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D005269:Femur / Q000737:chemistry; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D009765:Obesity; D013131:Spine / Q000737:chemistry; D013739:Testosterone / Q000031:analogs & derivatives* / Q000097:blood / Q000172:deficiency / Q000627:therapeutic use
chemical_list: D000728:Androgens; D013739:Testosterone; C010792:testosterone undecanoate