The effect of testosterone therapy on lower urinary tract symptoms/bladder and sexual functions in men with symptomatic late-onset hypogonadism

Objective.?To prospectively investigate the effect of testosterone therapy on lower urinary tract symptoms (LUTS)/bladder and sexual functions in men with symptomatic late-onset hypogonadism (SLOH).

Methods.?The study included 25 men (age range 38 to 73 years) presented with sexual dysfunction, having SLOH, at a single university hospital. All men received testosterone replacement therapy with transdermal testosterone 50–100 mg gel per day for one year. Urodynamic studies with pressure-flow analysis, measurement of prostate volume, prostate specific antigen (PSA) and free PSA level, International Prostate Symptom Score (IPSS), Aging Male Symptom (AMS) scale and International Index of Erectile Function (IIEF-5) score were recorded in all men before and after one year of the treatment.

Results.?The mean AMS score significantly decreased from 40.4 ± 7.3 to 28.8 ± 5.31 (p = 0.001), and mean IIEF-5 score significantly increased from 8.84 ± 3.76 to 14.36 ± 3.62 (p = 0.001). The mean maximal bladder capacity and compliance significantly increased (p = 0.007 and p = 0.032, respectively), and mean detrusor pressure at Qmax significantly decreased from pre-treatment to post-treatment (p = 0.017).

Conclusion.?This study suggests that in addition to improvement in sexual functions, testosterone therapy may also improve LUTS/bladder functions by increasing bladder capacity and compliance and decreasing detrusor pressure at maximal flow in men with SLOH.     

The effect of 6 months of androgen deprivation therapy on muscle and fat mass in older men with localized prostate cancer

Objective.?To evaluate body composition changes, specifically skeletal muscle mass, in men receiving androgen deprivation with luteinizing-hormone releasing hormone-agonist (LHRH-A) for prostate cancer (PCa) in comparison with healthy controls.

Design.?Retrospective analysis of body composition changes in men with prostate cancer receiving LHRH-A therapy from 2 clinical trials compared to men without prostate cancer serving as a placebo-control in another clinical trial.

Setting.?Clinical Research Center in Connecticut.

Participants.?Thirty men (> 60 years) receiving 6 months of LHRH-A therapy for PCa were compared to a healthy group of 25 men without PCa.

Measurements.?Appendicular skeletal muscle/height² (ASM/ht²), lean and fat mass were assessed by dual energy x-ray absorptiometry. Total testosterone levels were assessed by enzyme immunoassay.

Results.?At baseline, 12/30 (40%) of the treatment group and 7/25 (28%) of the control group (p = 0.11) met criteria for sarcopenia. There were no differences between control groups in ASM/ht² or lean mass. The LHRH-A group had a higher percent body fat than the control group, 29.8 ± 6.3 versus 26.3 ± 4.6 (p = 0.02). ASM/ht² and lean mass decreased in the LHRH-A group from 7.5 ± 0.9 kg to 7.3 ± 0.9 kg (?2.3% ± 0.03; p ? 0.001) and 53.5 ± 5.4 kg to 52.3 ± 5.3 kg (?2.1% ± 0.03; p ? 0.001), respectively. There was no muscle loss in the control group. At 6 months, the LHRH-A group had increased percent body fat from 29.8 ± 6.4 to 32.2 ± 5.8 (9.5% ± 0.13; p ? 0.001), whereas the control group had decreased in percent body fat from 26.6 ± 4.6 to 25.3 ± 5.0 (?3.8% ± 0.08; p = 0.02).

Conclusions.?Men undergoing LHRH-A treatment for PCa decreased appendicular skeletal muscle and lean tissue and increased body fat within 6 months of initiation of therapy. Lifestyle changes or medical interventions to minimize the effects of androgen deprivation therapy for PCa deserve investigation.     

Daily use of sildenafil 50mg at night effectively ameliorates nocturia in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: an exploratory multicenter,double-blind,randomized, placebo-controlled study

Purpose: To compare the efficacy and safety of sildenafil 25?mg qd, 25?mg bid or 50?mg qd – on treating lower urinary tract symptoms with benign prostatic hyperplasia (LUTS/BPH).

Materials and methods: Men aged?>?45 years with LUTS/BPH were randomly assigned to receive sildenafil 25?mg qd (n?=?42), bid (n?=?41), 50?mg qd (n?=?38) or placebo (n?=?41) for 8 weeks. Changes from baseline in International Prostate Symptom Score (I-PSS), maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) were assessed at week 4 and week 8.

Results: Sildenafil 25?mg qd (-7.3?±?5.8) and 25?mg bid (-7.0?±?5.7) exhibited significant improvements of I-PSS compared to placebo (-5.2?±?6.4) (p?=?0.020, 0.025, respectively). In particular, voiding domain was more affected than storage domain. Only sildenafil 50?mg qd improved nocturia significantly (versus placebo, p?=?0.027). Quality of life score was improved in all treatment groups. Q_max and PVR did not change significantly in all groups. All regimens were well tolerated.

Conclusions: Sildenafil 25?mg qd, 25?mg bid and 50?mg qd are safe and effective to improve LUTS/BPH in long term, along with coexisting ED. In particular, nocturia is most well-controlled by 50?mg qd.     

Prevalence of low forearm bone mineral density in Bulgarian men: a pilot study

Objective. To determine the prevalence of osteoporosis at the distal forearm in a male cohort referred for bone density testing and to compare it to published data of Bulgarian women.

Design and subjects. 315 consecutive Bulgarian men aged 20 to 84 years were included (mean age 53.74 ± 14.67 years). 59% of them were self-referrals. The comparative female group consisted of 8869 Bulgarian women whose forearm bone mineral density (BMD) was measured in another study.

Measurements. BMD was measured by single X-ray absorptiometry at the distal forearm (distal and ultradistal sites) in all men. T-scores were calculated from manufacturer-provided Danish male reference data.

Results. The ratio of female to male patients was 28.2 (8869 to 315). Peak BMD was observed in men aged 30 to 39 years: 0.560 ± 0.065 g/cm² (distal site) and 0.490 ± 0.070 g/cm² (ultradistal site). A steady BMD decline followed reaching 0.492 ± 0.064 g/cm² at the distal and 0.412 ± 0.069 g/cm² at the ultradistal site in age group >70. Age had a rather weak negative impact on forearm BMD described by a linear model. In men aged over 50 years the prevalence of osteoporosis at the distal site was 21.19%, compared to 20.45% in women. Low bone mass was seen in 48.77% of men and 32.50% of women. Normal BMD was more frequent in women (47.05%) than in men (30.04%).

Conclusions. We found a high prevalence of forearm osteoporosis in Bulgarian men which is comparable to that already known in women.     

A randomized,double-blind,placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up

Introduction: The clinical significance of low to low-normal testosterone (T) levels in men remains debated. Aim: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL). Methods: Randomized, double-blind, placebo-controlled study. Men, aged 50–80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males’ Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5–7.5?mg/day; n =183) or placebo gel (n =179), followed by 12 months open-label with T in all. Results: After 6 months, LBM increased in T- treated patients by 1.28?±?0.15?kg (mean ± SE) and FM decreased by 1.16?±?0.16?kg, with minor changes with placebo (LBM +0.02?±?0.10?kg and FM ?0.14?±?0.12?kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo). Conclusions: Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.     

Erectile dysfunction,loss of libido and low sexual frequency increase the risk of cardiovascular disease in men with low testosterone

Introduction: Testosterone deficiency increases the cardiovascular disease (CVD) risk.

Aim: To evaluate the effect of erectile dysfunction (ED), sexual frequency and hypogonadal symptoms on CVD risk.

Methods: A total of 395 hypogonadal men aged 45–74 years were surveyed using the Androgen Deficiency in the Aging Male and the International Index of Erectile Function.

Main outcome measures: The 10-year CVD risk was measured with the Framingham Risk Score. Logistic regression was performed to obtain the odds ratios of sexual function and hypogonadal symptoms for a 10-year CVD risk ≥20% (high risk).

Results: The mean age was 56.1?±?6.7 years. The mean 10-year CVD risk of the whole cohort was 18.1%?±?11.4%, while 131 subjects (33.2%) were classified as high risk. Logistic regression revealed that ED severity was associated with CVD risk [OR?=?2.37 (CI 1.24–4.51) for mild-to-moderate ED, OR?=?4.39 (1.78–8.43) for moderate ED and OR?=?12.81 (4.65–26.11) for severe ED]. Compared to sexual frequency <1 per month, sexual frequency?≥4 decreased the risk of high CVD risk [OR?=?0.35 (0.23–0.780)]. Loss of libido [OR?=?2.95 (1.91–4.12)] and less strong erection [OR?=?3.87 (CI 2.11–4.95)] increased the risk of high CVD risk. All remained significant after adjustment for age and testosterone.

Conclusions: ED, decreased sexual frequency and loss of libido predict a high 10-year CVD risk in hypogonadal men.     

Prevalence analysis of urinary incontinence after radical prostatectomy and influential preoperative factors in a single institution

Aims: To assess prevalence of urinary incontinence (UI) after radical prostatectomy (RP) and to analyze which preoperative characteristics of the patients have influence on UI.

Methods: Between 2002 and 2012, 746 consecutive patients underwent RP for clinically localized prostate cancer. We defined UI according to International Continence Society (ICS) definition: “the complaint of any involuntary leakage of urine” after 12?months of recovery, international consultation on incontinence questionnaire (ICIQ-SF) and pads/day was collected too. Clinical features and magnetic resonance imaging measurements were assessed. A multivariable logistic regression model predicting incontinence were built-in after adjust by cofounding factors and bootstrapping.

Results: About 172 (23%) of the patients were classified as incontinent according to the ICS definition. The mean value of the ICIQ-SF was 10.87 (±4). 17.8% of patients use at least one pad/day, 11.9% use more than one pad/day. The preoperative factors independently influential in UI are: age [OR: 1.055; CI 95% (1.006–1.107), p?=?.028], urethral wall thickness [OR: 5.03; CI 95% (1.11–22.8), p?=?.036], history of transurethral resection of the prostate [OR: 6.13; CI 95% (1.86–20.18), p?=?.003] and membranous urethral length [OR: 0.173; CI 95% (0.046–0.64), p?=?.009]. The predictive accuracy of the model is 78.7% and the area under the curve (AUC) value 71.7%.

Conclusions: Urinary incontinence after radical prostatectomy has different prevalence depending on the definition. Age, prior transurethral resection of the prostate (TURP), membranous urethral length (MUL) and urethral wall thickness (UWT) were risk factors.     

Mission Statement

Aim.?To investigate sex hormone and androgen receptor (AR) levels and to evaluate their relationship with diabetes mellitus (DM) in senile men.

Methods.?The cross-sectional study included 492 elderly men comprising 104 healthy subjects (mean age 71.4 ± 5.2 years), 259 subjects without DM (71.5 ± 5.0 years) and 129 DM patients (73.0 ± 6.3 years). Plasma concentrations of total testosterone (TT), free testosterone (FT), dehydroepiandrosterone sulphate, sex hormone-binding globulin (SHBG), estradiol (E₂), luteinising hormone) and follicle-stimulating hormone (FSH) were determined. AR-positive cells were measured by flow cytometry.

Results.?TT concentrations were significantly lower in the DM group (13.8 ± 4.7 nmol/l) than in the healthy (17.1 ± 6.1 nmol/l) and non-diabetes groups (15.8 ± 6.0 nmol/l; all P < 0.01). FT, SHBG, AR-positive proportion (AR%) and AR fluorescence intensity showed a decreasing trend among the healthy, non-DM and DM groups, but the differences were not significant. TT, E₂, E₂/testosterone and SHBG were negatively correlated with blood glucose. SHBG was positively correlated and TT and AR% were negatively correlated with the course of DM. Logistic multiple regression analysis revealed that age, waist/hip ratio, FSH, SHBG and AR% are potential risk factors for DM.

Conclusions.?Low levels of TT, SHBG and AR may be potential risk factors for DM in elderly men.     

Age influences anthropometric and fitness-related predictors of bone mineral in men

Objective. This study assessed the influence of age on the predictors of bone mineral in men.

Methods. Middle-age (n = 41, 54 ± 4 yrs) and older (n = 40, 69 ± 5 yrs) men underwent grip and knee extensor strength tests, total body dual-energy X-ray absorptiometry with regional analyses and a graded exercise treadmill test.

Results. Bone-free lean mass (BFLM) and, to a lesser extent, fat mass (FM) were correlated with bone mineral variables in middle-age men. In older men, BFLM and, to a lesser extent, FM were related to bone mineral content (BMC) at most sites, but inconsistently to bone mineral density (BMD). Knee extensor strength related to bone mineral (BMC and BMD) at most sites in middle-age men, but none in older men. Grip strength inconsistently related to bone mineral in both groups. Aerobic capacity related to bone mineral in middle-age men, but none in older men. In multiple regression, body weight or BFLM predicted bone mineral in middle-age men (R² = 0.33–0.68) and BMC in older men (R² = 0.33–0.50). Predictors of BMD were inconsistent in older men.

Conclusions. Relationships of body composition, muscular strength and aerobic capacity to bone mineral are stronger in middle-age versus older men.     

The relationship between serum total testosterone and free testosterone levels with serum hemoglobin and hematocrit levels: a study in 1221 men

Objective: To investigate the relationship between serum total testosterone (TT) and free testosterone (FT) levels in men with anemia.

Methods: We reviewed the records of 1221 subjects between March 2009 and December 2014. All the subjects’ blood samples were drawn for TT and FT assays. Their serum hemoglobin (Hb) and serum hematocrit (Hct) levels were measured. The primary objective of our study was to investigate the association between TT and FT levels with Hb and Hct levels.

Results: The mean age was 59.82?±?12.71 years. The mean TT and FT levels were 4.54?±?2.02?ng/mL and 10.63?±?3.69?pg/mL, respectively. The mean Hb and Hct levels were 14.72?±?1.34?g/dL and 43.11?±?3.75%, respectively. Subjects with low TT (<2.35?ng/mL) had low Hb and Hct levels (p?p?Conclusions: Subjects with low TT and FT levels had low Hb and Hct levels. This suggests that TT and FT play a significant role in erythropoiesis. Testosterone replacement therapy may be effective in men with hypogonadism to reduce the incidence of anemia.     

Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year,randomized, placebo-controlled,dose-ranging study

Abstract

Objective: We investigated the effects of oral testosterone undecanoate (TU) on bone mineral density (BMD), lean body mass (LBM) and body fat mass (BFM) in aging men with symptomatic testosterone deficiency (TD).

Methods: Three hundred twenty-two men ≥50 years with TD symptoms and calculated free testosterone <0.26?nmol/L participated in a multicenter, double-blind, placebo-controlled trial. Patients were randomized to placebo, oral TU 80?mg/d, oral TU 160?mg/d, or oral TU 240?mg/d, administered as divided doses with normal meals. BMD of the hip and lumbar spine were evaluated by dual energy X-ray absorptiometry (DEXA), and body composition (LBM and BFM) by whole body DEXA.

Results: Oral TU significantly increased BMD at Month 12 at the lumbar spine (240?mg/d), total hip (240?mg/d), and trochanter and intertrochanter (160 and 240?mg/d) compared with placebo. Oral TU significantly increased LBM at Months 6 and 12 for all oral TU groups compared with placebo. BFM significantly decreased at Month 6 (all oral TU groups) and Month 12 (160?mg/d) compared with placebo. The effects on BMD and body composition showed a clear dose response.

Conclusions: Treatment with oral TU led to improvement in BMD, LBM and BFM in aging men with symptomatic TD.     

Visceral adiposity index is associated with premature ejaculation inversely: a cross-sectional study

Objective: Visceral adiposity index (VAI) is a novel indicator for the assessment of visceral obesity. In this study, we aimed to evaluate the relationship between VAI and premature ejaculation (PE).

Materials and method: A total of 300 men were included in the study. Hundred and fifty men with PE and 150 men without PE (control). All men were evaluated for PE by premature ejaculation diagnostic tool (PEDT). VAI levels were calculated using body mass index (BMI), high density lipoprotein and triglyceride (TG) levels.

Results: Mean age of the study groups was 34.3?±?5.2 (30–60) years and the mean age of the controls were 35.9?±?5.3 (30–60) years. The men with PE had lower BMI, TG levels, waist circumference (WC) and higher high-density lipoprotein-cholesterol (HDL-C) levels. Mean VAI level was 4.13?±?0.7 in study group and 5.72?±?1.6 in control group, respectively. VAI levels were statistically higher in men without PE (p?Discussion: Our cross-sectional study demonstrated a negative correlation between VAI and PE. VAI is superior index for the evaluation and calculation the relationship between obesity and PE.     

Effect of testosterone therapy on lumbar spine and hip mineral density in elderly men

Objective.?The aim of the present study was to analyse the effect of testosterone therapy on bone mineral density in healthy elderly men who had low levels of total testosterone.

Design.?Randomized, double-blind, placebo-controlled study.

Participants.?Forty-eight men over 60 years old with decreased testosterone levels (≤320 ng/dL) comprised the study. Twenty-five out of 48 received intramuscular injections of testosterone enanthate every three weeks during 12 months; the remaining 23 participants formed the control group. All participants had measurements of bone mineral density (BMD) in both lumbar spine and hip before and at the end of the study as well as testosterone and 17-β estradiol levels.

Results:?Testosterone treated group exhibited a significant (p < 0.05) increment (from 1.198 ± 0.153 to 1.240 ± 0.141 g/cm²) in lumbar BMD in parallel with a significant (p < 0.001) increment (from 301 ± 32 to 471 ± 107 ng/dL) in testosterone concentrations, whereas no significant change occurred in femoral neck BMD.

Conclusions.?Testosterone therapy elicited a positive effect only in lumbar BMD in elderly men with diminished testosterone serum levels.     

The imbalance of sex-hormones related to depressive symptoms in obese men

Obese men may present hypogonadothrofic hypogonadism, mainly related to higher insulinemia and aromatase activity. Our objectives were to evaluate the relationship of sex-hormones profiles and frequency of depressive symptoms in 43 obese men, in a cross-sectional study. They had 19–60 years, and body mass index 30–50?kg/m². LH, total and free testosterone (TT and FT), estradiol (E₂), sex hormone binding globulin, estradiol/total testosterone ratio (E₂/T) were analyzed. Depressive symptoms were evaluated by “beck depression inventory” (BDI), and significant depression was considered if BDI?≥?16.Thirty-four (80%) presented low TT levels, but only 4 (14%) had low free testosterone and hypogonadism symptoms; 12 of 43 (28%) presented increased E₂. Forty five (56%) presented depressive symptoms, but 16 (28% of the 45) had significant depression. BDI correlated positively with E₂ (r?=?0.407; p?=?0.001) and E₂/T (r?=?0.473; p?=?0.001), but not TT or FT. Patients with significant depressive showed higher levels of estradiol (136?±?48 versus 103?±?48?pg/ml, p?=?0.02) and E₂/T (16.0?±?9.9 versus 9.8?±?4.6; p?=?0.002) (mean?±?SD).In conclusion, obese men may present relatively excess of estradiol and deficiency in testosterone, leading to an imbalance between these two hormones. The greater this imbalance, the more depressive symptoms had our patients.     

Interleukin-18 and testosterone levels in men with metabolic syndrome

Objective: Interleukin 18 (IL-18) is an adipokine associated with obesity. Data about the relationship of IL-18 to the metabolic syndrome (MS) are still scarce. Low testosterone (T) levels are common in men with MS, but we did not find data about the levels of IL-18 in men with low T. The aim of this study was to determine the levels of IL-18 in men with MS with or without low T.

Patients and methods: A total of 251 men were included in the study. Of them 218 had MS (IDF 2005) and they were divided according to their morning total testosterone (TT) level (cutoff 10.4?nmol/l) into two groups: MS-low T (N?=?84) and MS-normal T (N?=?134). The control group consisted of 33 men without MS and low T. IL-18 was determined in serum using enzyme-linked immunosorbent assay. A small group of eight men with MS and low T levels received testosterone therapy for three months and physical and laboratory parameters were monitored at the end of that period.

Results: MS men were at mean age (±SD)?=?53.77?±?9.59 years; body mass index (BMI)?=?34.0?±?6.3?kg/m²; and TT?=?12.59?±?5.66?nmol/l. The control group was at age?=?52.12?±?5.2 years (NS); BMI?=?25.6?±?2.4?kg/m² (p?p?p?p?p?p?Conclusions: In this study, higher IL-18 levels were found in the presence of MS compared to healthy men, but they did not differ between men having MS with or without LOH.     

Evaluation of sex hormone levels and some metabolic factors in men with coronary atherosclerosis

Background Because of the great controversy over the role of androgens in the pathogenesis of atherosclerosis, we investigated the relationship between serum sex hormone levels and angiographically confirmed coronary artery disease in men.

Material and methods We investigated 86 men aged 40–60 years, 56 with coronary artery disease and 30 healthy men, matched by age, as a control group. Body mass index and waist to hip ratio were calculated and total body fat mass and percentage of abdominal deposit were investigated by dual-energy X-ray absorptiometry (Dpx (?+?) Lunar, USA). The serum levels of sex hormones and insulin were measured using commercial radioimmunoassay and IRMA (by SHBG) kits (DPC, USA). The serum levels of lipids and glucose were assessed by means of enzymatic methods.

Results Men with coronary artery disease had lower total testosterone levels (17.01?±?6.42 vs. 19.37?±?6.58?nmol/l; p?<?0.05), testosterone/estradiol ratio (228.5?±?88.5 vs. 289.8?±?120.1; p?<?0.05) and free androgen index (FAI) (59.49?±?14.79 vs. 83.03?±?25.81; p?<?0.0001), and higher levels of estrone (49.5?±?27.7 vs. 36.6?±?12.7?pg/ml) than men in the control group. Moreover, men with coronary artery disease were more insulin-resistant than controls and had an atherogenic lipid profile. There was an inverse correlation (p?<?0.05) between testosterone level and serum level of glucose (r?=??0.29), triglycerides (r?=??0.37), body mass index (r?=??0.55), waist (r?=??0.43), total body fat mass (r?=??0.3) and fasting insulin resistance index. A significant positive association (p?<?0.05) was found between testosterone and the quantitative insulin sensitivity check index and high density lipoprotein cholesterol level in serum (r?=?0.26).

Conclusions Low levels of total testosterone, testosterone/estradiol ratio and free androgen index and higher levels of estrone in men with coronary artery disease appear together with many features of metabolic syndrome and may be involved in the pathogenesis of coronary atherosclerosis.     

Androgen replacement therapy contributes to improving lower urinary tract symptoms in patients with hypogonadism and benign prostate hypertrophy: a randomised controlled study

Purpose.?We performed a randomised controlled study regarding the effects of androgen replacement therapy (ART) on lower urinary tract symptoms (LUTS) in hypogonadal men with benign prostate hypertrophy (BPH).

Methods.?Fifty-two patients with hypogonadism and BPH were randomly assigned to receive testosterone (ART group) as 250?mg of testosterone enanthate every 4 weeks or to the untreated control group. We compared International Prostate Symptom Score (IPSS), uroflowmetry data, post-voiding residual volume (PVR) and systemic muscle volume at baseline and 12 months after treatment.

Results.?Forty-six patients (ART group, n?=?23; control, n?=?23) were included in the analysis. At the 12-month visit, IPSS showed a significant decrease compared with baseline in the ART group (15.7?±?8.7 vs. 12.5?±?9.5; p?<?0.05). No significant changes were observed in the control group. The ART group also showed improvement in maximum flow rate and voided volume (p?<?0.05), whereas no significant improvements were observed in the controls. PVR showed no significant changes in either group. In addition, the ART group showed significant enhancement of mean muscle volume (p?<?0.05), whereas no significant changes were seen in the controls.

Conclusion.?ART improved LUTS in hypogonadal men with mild BPH.     

Effects of testosterone replacement therapy on hypogonadal men with osteopenia or osteoporosis: a subanalysis of a prospective randomized controlled study in Japan (EARTH study)

Objective: We investigated the effects of testosterone replacement therapy (TRT) on bone mineral density (BMD) among hypogonadal men with osteopenia/osteoporosis.

Methods: From our previous EARTH study population, 74 patients with a clinical diagnosis of osteopenia or osteoporosis and hypogonadism were included in this study, as the TRT (n?=?35) and control (n?=?34) groups. The TRT group was administered 250?mg of testosterone enanthate injection every 4 weeks for 12 months. The BMD, waist circumference, body mass index, body fat percentage, and muscle volume were measured at baseline and at 12 months. Blood biochemical data, including total cholesterol, triglycerides, HDL-cholesterol, hemoglobin A1c, and adiponectin values were also evaluated.

Results: At the 12-month visit, BMD significantly increased in both groups. However, comparisons on changes of parameter values from baseline to the 12-month visit between the TRT and control groups were significantly different in BMD (5.0?±?5.0 vs. 3.0?±?3.2; p?=?.0434) and in adiponectin value (?0.90?±?3.33 vs. 0.10?±?2.04; p?=?.0192). There were no significant changes in other parameters.

Conclusions: TRT for 12 months could improve BMD with a decrease in adiponectin levels among hypogonadal men with osteopenia/osteoporosis.