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RELATIONSHIP OF HORMONAL STATUS AND BONE STATE IN MEN
8th European Congress on Menopause (EMAS) / Maturitas 63, Supplement 1 (2009) S1–S136
3 whether the increase in plasma testosterone upon testosterone administration was a co-determinant of the beneficial effects of testosterone on the metabolic syndrome. Results: Neither age nor baseline testosterone values nor the increment in plasma testosterone showed a relationship with the beneficial effects of restoring testosterone levels to normal on the following features of the metabolic syndrome: waist circumference, Cholesterol, HDL, LDL and triglycerides. Conclusions: Hypogonadal men of advanced age with the metabolic syndrome benefit as much as younger men from normalizing testosterone. Neither the degree of testosterone deficiency nor the increment in plasma testosterone not predicted the measure of improvements of the metabolic syndrome. Keywords: Testosterone, age, plasma level, metabolic syndrome.
119 SAFETY STUDY OF LONG-ACTING PARENTERAL TESTOSTERONE OVER 24-30 MONTHS F. Saad. Bayer-Schering Pharma, Men’s Healthcare, Berlin, Germany Objectives: To investigate the safety of long-acting parenteral testosterone undecanoate (TU) to hypogonadal, mainly elderly men. Methods: 122 men aged 34 - 69 years (mean ± SD = 59.5±6.0), with baseline testosterone 5.9 - 12.1 nmol/L (mean ± SD = 2.7±0.5) were treated with parenteral TU. Of these 122 patients, 48 patients were followed for up to 30 months, 27 for 27 months and 47 for 24 months. Results: Plasma levels of testosterone rose from 9.3±1.7 nmol/L to 18.7±2.1 nmol/L reaching their maximum at 9 months, never exceeding reference values. International Prostate Symptoms Scores decreased significantly over 24 months (p<0.001), and then stabilized. There were initial fluctuations in prostate volume and values of PSA over the first 12-15 months treatment, then values stabilized at levels of 5-10% higher than baseline. PSA never exceeded 4 ng/mL. Hemoglobin increased significantly (p<0.001) never exceeding reference values. The hematocrit increased significantly (p<0.001). Both had reached their maximum values after 12 months. Over the 30 month study period, at any time point, nine patients had a hematocrit above 52%, the upper limit of normal. No specific measures were taken (dose reduction of testosterone, venipuncture). An elevated hematocrit was never found at two occasions in the same patient. Conclusions: Over a period of 24-30 months testosterone treatment with TU appeared safe but longer and larger scale studies are needed. Keywords: Testosterone undecanoate, drug safety, polycythaemia, prostate cancer.
S33
Percent of revealing of T deficiency in men determine by different methods: FT (UF) - 38%, TT - 20%, FT in saliva - 18%, CFT - 15%.Salivary T concentration in healthy women 17-39 years was 87 (55-210), in postmenopausal group -73 (25-116) and androgen deficient women -23 (18-250 pmol/L). – ELISA: Measurement of FT in saliva and ultrafiltrate with ELISA unacceptable, it produced significant positive bias in comparison with LIA. Conclusions: The level of FT measured by LIA method in serum after UF and in saliva can be used as additional sensitive and informative biomarker for assessment of androgen status in men and women. Keywords: Free testosterone, immunoassay, ultrafiltration.
121 RELATIONSHIP OF HORMONAL STATUS AND BONE STATE IN MEN V. Povoroznyuk, T. Orlyk, Y. Kreslov. Institute of Gerontology AMS Ukraine, Department of Clinical Physiology and Pathology of Locomotor Apparatus, Kyiv, Ukraine Objectives: The aim was to determine the relationship of hormonal status and bone state in men. Methods: We have examined 96 men aged from 30 to 79 years (M ± m): age - 54,4±1,3 years, divided them into age dependent subgroups 30-49 (n=36; age - 41,2±1,2 years) and 50-79 years (n=60; age - 64,4±1,1 years). Levels of testosterone (Test, nmoll) and sex hormone-binding globulin (SHBG, nmoll) were determined by means of chemiluminescent immunoanalysis method. The bone mineral density (BMD, g/cm2 ) was evaluated for the total body, spine (L1 -L4 ), femur and radius using dual energy x-ray absorptiometry by the Prodigy instrument (GE Medical systems, 2005). Results: The correlation analysis of age dependent sub-groups: in the group of 30-49 years there is a positive correlation between Test and BMD ultradistal radius (r=0,49, p<0,05), along with the negative correlation between SHBG and Total body in the group of 50-79 years (r=-0,31, p<0,05). In the group of 60-79 years (n=38; age - 69,7±1,0 years) we have found a negative correlation between SHBG and Total body (r=- 0,60, p<0,001), SHBG and trochanter (r=-0,47, p<0,05), SHBG and Total femur (r=-0,48, p<0,05). Conclusions: We have revealed a positive correlation between testosterone levels and ultradistal radius BMD and negative correlation between SHBG and total body BMD in patients of 50 - 79 year age group, trochanter and total femur in patients of 60 - 79 year age group. Keywords: Age, men, testosterone, sex hormone-binding globulin, bone mineral density.
122 TIME FOR INTERNATIONAL ACTION ON TREATING TESTOSTERONE DEFICIENCY SYNDROME
120 ASSESSMENT OF ANDROGEN STATUS IN MEN AND WOMEN USED FREE TESTOSTERONE AS MARKER: COMPARE ELISA AND ULTRASENSITIVE IMMUNOLUMINESCENCE METHODS N. Goncharov, G. Katsya, N. Malysheva. Endocrinology Research Center, Moscow, Russian Federation Objectives: Direct methods measure level of total testosterone (TT) unacceptable for women and children, and critical for men (TT<10 nmol/L). The aim of the study was evaluation of ELISA and enhances luminescence (LIA) methods for measuring free testosterone (FT) in saliva and sera, and calculated FT (CFT) as well. Methods: Serum and saliva samples were taken in morning from 189 men in age 22-75 years and 58 women 18-69 years. TT and SHBG in serum were measured by automated analyzers Vitros ECi and Elecsys2010 respectively. FT in sera after ultrafiltration (UF) (Millipore’s Amicon Ultra-4 centrifugal filter devices 30K) and in saliva were measured quantitatively by LIA and ELISA (IBL-Hamburg, Germany). Results: – LIA: Levels of FT (median and 10th-90th percentiles) Men
TT nmol/L
FT pmol/L saliva
in blood(CFT)
serum(UF)
TT > 10 nmol/L (n=148) 16.9 (13.1-21.4) 393 (312-534) 298 (253-404) 148 (101-199) TT < 10 nmol/L (n=41) 8.2 (5.7-9.3) 262 (219-357) 159 (113-197) 83 (33-126)
M. Carruthers. Centre for Mens Health, London, United Kingdom Objectives: Testosterone deficiency is having an increasing impact on men’s health because of global aging, increasing obesity, diabetes and environmental factors and an explanation is needed why so few androgen deficient men are being treated. Methods: Demographic data for men over the age of 50 from different regions of the world have been compared with the number of men in that age group estimated from sales figures to be receiving testosterone treatment. Results: Based on the 20% of men over 50 in the general population who are expected to have testosterone deficiency symptoms, on average only 0.69% these men in most European countries were receiving treatment. The proportion was higher in the UK (1.00%) and Germany (1.89%), but lower in France (0.49%), Italy (0.51%) and Russia (0.54%). Australia had higher figures (1.64%), in spite of tight state control measures on androgen use. The USA has the highest treatment rate (7.96%) and this is increasing rapidly. Based on symptoms plus low total and free testosterone levels, androgen deficiency would be diagnosed in at least 5% of men over 50, and percentage treatment rates therefore four times higher. However, even on that basis, only in the USA do these exceed 10%. Conclusions: International action is urgently needed to raise awareness in the medical profession in the various countries of these unacceptably low levels of testosterone treatment. Improvement in this requires education and motivation of doctors and those regulating the healthcare systems. Keywords: Testosterone deficiency syndrome, treatment, demographics, andropause, Aging Male Symptoms.
3 whether the increase in plasma testosterone upon testosterone administration was a co-determinant of the beneficial effects of testosterone on the metabolic syndrome. Results: Neither age nor baseline testosterone values nor the increment in plasma testosterone showed a relationship with the beneficial effects of restoring testosterone levels to normal on the following features of the metabolic syndrome: waist circumference, Cholesterol, HDL, LDL and triglycerides. Conclusions: Hypogonadal men of advanced age with the metabolic syndrome benefit as much as younger men from normalizing testosterone. Neither the degree of testosterone deficiency nor the increment in plasma testosterone not predicted the measure of improvements of the metabolic syndrome. Keywords: Testosterone, age, plasma level, metabolic syndrome.
119 SAFETY STUDY OF LONG-ACTING PARENTERAL TESTOSTERONE OVER 24-30 MONTHS F. Saad. Bayer-Schering Pharma, Men’s Healthcare, Berlin, Germany Objectives: To investigate the safety of long-acting parenteral testosterone undecanoate (TU) to hypogonadal, mainly elderly men. Methods: 122 men aged 34 - 69 years (mean ± SD = 59.5±6.0), with baseline testosterone 5.9 - 12.1 nmol/L (mean ± SD = 2.7±0.5) were treated with parenteral TU. Of these 122 patients, 48 patients were followed for up to 30 months, 27 for 27 months and 47 for 24 months. Results: Plasma levels of testosterone rose from 9.3±1.7 nmol/L to 18.7±2.1 nmol/L reaching their maximum at 9 months, never exceeding reference values. International Prostate Symptoms Scores decreased significantly over 24 months (p<0.001), and then stabilized. There were initial fluctuations in prostate volume and values of PSA over the first 12-15 months treatment, then values stabilized at levels of 5-10% higher than baseline. PSA never exceeded 4 ng/mL. Hemoglobin increased significantly (p<0.001) never exceeding reference values. The hematocrit increased significantly (p<0.001). Both had reached their maximum values after 12 months. Over the 30 month study period, at any time point, nine patients had a hematocrit above 52%, the upper limit of normal. No specific measures were taken (dose reduction of testosterone, venipuncture). An elevated hematocrit was never found at two occasions in the same patient. Conclusions: Over a period of 24-30 months testosterone treatment with TU appeared safe but longer and larger scale studies are needed. Keywords: Testosterone undecanoate, drug safety, polycythaemia, prostate cancer.
S33
Percent of revealing of T deficiency in men determine by different methods: FT (UF) - 38%, TT - 20%, FT in saliva - 18%, CFT - 15%.Salivary T concentration in healthy women 17-39 years was 87 (55-210), in postmenopausal group -73 (25-116) and androgen deficient women -23 (18-250 pmol/L). – ELISA: Measurement of FT in saliva and ultrafiltrate with ELISA unacceptable, it produced significant positive bias in comparison with LIA. Conclusions: The level of FT measured by LIA method in serum after UF and in saliva can be used as additional sensitive and informative biomarker for assessment of androgen status in men and women. Keywords: Free testosterone, immunoassay, ultrafiltration.
121 RELATIONSHIP OF HORMONAL STATUS AND BONE STATE IN MEN V. Povoroznyuk, T. Orlyk, Y. Kreslov. Institute of Gerontology AMS Ukraine, Department of Clinical Physiology and Pathology of Locomotor Apparatus, Kyiv, Ukraine Objectives: The aim was to determine the relationship of hormonal status and bone state in men. Methods: We have examined 96 men aged from 30 to 79 years (M ± m): age - 54,4±1,3 years, divided them into age dependent subgroups 30-49 (n=36; age - 41,2±1,2 years) and 50-79 years (n=60; age - 64,4±1,1 years). Levels of testosterone (Test, nmoll) and sex hormone-binding globulin (SHBG, nmoll) were determined by means of chemiluminescent immunoanalysis method. The bone mineral density (BMD, g/cm2 ) was evaluated for the total body, spine (L1 -L4 ), femur and radius using dual energy x-ray absorptiometry by the Prodigy instrument (GE Medical systems, 2005). Results: The correlation analysis of age dependent sub-groups: in the group of 30-49 years there is a positive correlation between Test and BMD ultradistal radius (r=0,49, p<0,05), along with the negative correlation between SHBG and Total body in the group of 50-79 years (r=-0,31, p<0,05). In the group of 60-79 years (n=38; age - 69,7±1,0 years) we have found a negative correlation between SHBG and Total body (r=- 0,60, p<0,001), SHBG and trochanter (r=-0,47, p<0,05), SHBG and Total femur (r=-0,48, p<0,05). Conclusions: We have revealed a positive correlation between testosterone levels and ultradistal radius BMD and negative correlation between SHBG and total body BMD in patients of 50 - 79 year age group, trochanter and total femur in patients of 60 - 79 year age group. Keywords: Age, men, testosterone, sex hormone-binding globulin, bone mineral density.
122 TIME FOR INTERNATIONAL ACTION ON TREATING TESTOSTERONE DEFICIENCY SYNDROME
120 ASSESSMENT OF ANDROGEN STATUS IN MEN AND WOMEN USED FREE TESTOSTERONE AS MARKER: COMPARE ELISA AND ULTRASENSITIVE IMMUNOLUMINESCENCE METHODS N. Goncharov, G. Katsya, N. Malysheva. Endocrinology Research Center, Moscow, Russian Federation Objectives: Direct methods measure level of total testosterone (TT) unacceptable for women and children, and critical for men (TT<10 nmol/L). The aim of the study was evaluation of ELISA and enhances luminescence (LIA) methods for measuring free testosterone (FT) in saliva and sera, and calculated FT (CFT) as well. Methods: Serum and saliva samples were taken in morning from 189 men in age 22-75 years and 58 women 18-69 years. TT and SHBG in serum were measured by automated analyzers Vitros ECi and Elecsys2010 respectively. FT in sera after ultrafiltration (UF) (Millipore’s Amicon Ultra-4 centrifugal filter devices 30K) and in saliva were measured quantitatively by LIA and ELISA (IBL-Hamburg, Germany). Results: – LIA: Levels of FT (median and 10th-90th percentiles) Men
TT nmol/L
FT pmol/L saliva
in blood(CFT)
serum(UF)
TT > 10 nmol/L (n=148) 16.9 (13.1-21.4) 393 (312-534) 298 (253-404) 148 (101-199) TT < 10 nmol/L (n=41) 8.2 (5.7-9.3) 262 (219-357) 159 (113-197) 83 (33-126)
M. Carruthers. Centre for Mens Health, London, United Kingdom Objectives: Testosterone deficiency is having an increasing impact on men’s health because of global aging, increasing obesity, diabetes and environmental factors and an explanation is needed why so few androgen deficient men are being treated. Methods: Demographic data for men over the age of 50 from different regions of the world have been compared with the number of men in that age group estimated from sales figures to be receiving testosterone treatment. Results: Based on the 20% of men over 50 in the general population who are expected to have testosterone deficiency symptoms, on average only 0.69% these men in most European countries were receiving treatment. The proportion was higher in the UK (1.00%) and Germany (1.89%), but lower in France (0.49%), Italy (0.51%) and Russia (0.54%). Australia had higher figures (1.64%), in spite of tight state control measures on androgen use. The USA has the highest treatment rate (7.96%) and this is increasing rapidly. Based on symptoms plus low total and free testosterone levels, androgen deficiency would be diagnosed in at least 5% of men over 50, and percentage treatment rates therefore four times higher. However, even on that basis, only in the USA do these exceed 10%. Conclusions: International action is urgently needed to raise awareness in the medical profession in the various countries of these unacceptably low levels of testosterone treatment. Improvement in this requires education and motivation of doctors and those regulating the healthcare systems. Keywords: Testosterone deficiency syndrome, treatment, demographics, andropause, Aging Male Symptoms.