scholarly journals SAT-044 Treatment of Hypogonadal Men with a New Oral Testosterone Undecanoate (TU) Formulation Improves Psychosexual, Well-Being and Body Composition and Bone Density Parameters

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Ronald S Swerdloff ◽  
John K Amory ◽  
Adrian S Dobs ◽  
Christina Wang ◽  
Theodore M Danoff ◽  
...  
Keyword(s):  
Body Composition ◽  
Well Being ◽  
Clinic Visit ◽  
Dose Titration ◽  
Mineral Density ◽  
Open Label ◽  
Testosterone Undecanoate ◽  
Active Comparator ◽  
Sf 36 ◽  
The Impact

Abstract Introduction and Objective: A new, first-in-class oral testosterone (T) replacement therapy product [T-undecanoate (TU) capsules] was recently approved by FDA to treat hypogonadal men. Clinical trials were conducted to evaluate, in part, the impact of oral TU therapy on important secondary efficacy endpoints: Psychosexual and/or general well-being (Trial I and II); and body composition and bone mineral density (BMD) (Trial II). Subject and Methods: Hypogonadal men (AM serum T ≤ 300 ng/dL) age 18 to 65 (Trial I) or 75 years old (Trial II) were randomized into open-label, active-comparator (T-gel/solution) trials. Subjects received: Trial 1: Oral TU (n=166) or a topical T solution (n=55) for 4-6 mos.; or Trial II: Oral TU (n=162) or T-gel (n=163) for 12 mos. The starting oral TU dose (with food) was 237 mg, BID in Trial I and 316 mg, BID in Trial II; up to 2 dose-titration opportunities were available to achieve eugonadal T concentrations (assayed by LC-MS/MS). In Trial I, Psychosexual Daily Questionnaires (PDQ) were completed by study subjects for 7 days at baseline and prior to final clinic visit (Day 105-180). In Trial II, the SF-36 well-being questionnaire was completed on Days 0, 30, 90, 180, 270 and 365 and PDQs were completed for 7 days prior to clinic visits on these same days. In Trial II body composition and BMD was assessed by DEXA scan on Days 0, 180 and 365. Safety was monitored by physical exam and standard clinical lab tests. Results: Mean serum T in response to oral TU was 489 ± 155 ng/dL (mean ± SD) (Trial I) and 628 ± 342 ng/dL (Trial II); 84% of subjects in each trial achieved mean T concentrations in the eugonadal range. Statistically significant mean changes from baseline (p<0.0001) for most SF-36 well-being parameters were observed in both oral TU and T-gel groups. Psychosexual questionnaire results also demonstrated statistically significant improvement over baseline (p<0.0001) in most parameters at Day 30 and all timepoints thereafter in both trials. On Days 180 and 365 (v. baseline) oral TU was associated with a significant reduction in fat mass [-1.92 ± 2.79 (SD) and -2.4 ± 3.6 kg, respectively] (p<0.0001) and an increase in lean body mass [+2.87 ± 2.73 and +3.15 ± 2.69 kg, respectively] (p<0.0001). Oral TU increased mean BMD over baseline on Days 180 and 365 in spine [+0.013 ± 0.035 and +0.018 ± 0.042 g/cm2, respectively (p<0.0001)] and hip [+0.006 ± 0.019 and +0.012 ± 0.023 g/cm2, respectively (p<0.0001)]. Oral TU exhibited a safety profile consistent with commonly prescribed topical T-comparators. Modest increases in cuff sBP of 2.8 ± 11.84 (SD) mm Hg and 1.8 ± 10.76 mm Hg were observed in Trial I for both oral TU and the comparator T-solution. Conclusions: Treatment of hypogonadal men with oral TU yielded circulating mean T concentrations in the mid-eugonadal range and significantly improved psychosexual, general well-being, body composition and BMD parameters comparable to transdermal T administration.

scholarly journals Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year

2005 ◽  
Vol 187 (2) ◽  
pp. 131-136 ◽  
Author(s):  
W. Wolfgang Fleischhacker ◽  
Jonathan Rabinowitz ◽  
Georg Kemmler ◽  
Mariëlle Eerdekens ◽  
Angelika Mehnert
Keyword(s):  
Mental Component Summary ◽  
Psychiatric Symptoms ◽  
Short Form ◽  
Mental Component Summary Score ◽  
Well Being ◽  
Psychotic Symptoms ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported ◽  
Long Acting

BackgroundThe extent to which antipsychotics improve patients' well-being is uncertain.AimsTo examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.MethodIn a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).ResultsSignificant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.ConclusionsPatient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

scholarly journals Ovine prenatal growth restriction impacts glucose metabolism and body composition throughout life in both sexes

Reproduction ◽  
2018 ◽  
Vol 156 (2) ◽  
pp. 103-119 ◽  
Author(s):  
Jacqueline M Wallace ◽  
John S Milne ◽  
Raymond P Aitken ◽  
Graham W Horgan ◽  
Clare L Adam
Keyword(s):  
Body Composition ◽  
Glucose Metabolism ◽  
Life Course ◽  
Growth Rates ◽  
Growth Restriction ◽  
Negative Consequences ◽  
Mineral Density ◽  
Prenatal Growth ◽  
The Life Course ◽  
The Impact

Low birthweight is a risk factor for later adverse health. Here the impact of placentally mediated prenatal growth restriction followed by postnatal nutrient abundance on growth, glucose metabolism and body composition was assessed in both sexes at key stages from birth to mid-adult life. Singleton-bearing adolescent dams were fed control or high nutrient intakes to induce normal or growth-restricted pregnancies respectively. Restricted lambs had ~40% reduced birthweight. Fractional growth rates were higher in restricted lambs of both sexes predominantly during suckling/juvenile phases. Thereafter, rates and patterns of growth differed by sex. Absolute catch-up was not achieved and restricted offspring had modestly reduced weight and stature at mid-adulthood necropsy (~109 weeks). Dual-energy X-ray absorptiometry revealed lower bone mineral density in restricted vs normal lambs at 11, 41, 64 and 107 weeks, with males > females from 41 weeks onwards. Body fat percentage was higher in females vs males throughout, in restricted vs normal lambs at weaning (both sexes) and in restricted vs normal females at mid-adulthood. Insulin secretion after glucose challenge was greater in restricted vs normal of both sexes at 7 weeks and in restricted males at 32 weeks. In both sexes, fasting glucose concentrations were greater in restricted offspring across the life course, while glucose area under the curve after challenge was higher in restricted offspring at 32, 60, 85 and 106 weeks, indicative of persistent glucose intolerance. Therefore, prenatal growth restriction has negative consequences for body composition and metabolism throughout the life course with the effects modulated by sex differences in postnatal growth rates, fat deposition and bone mass accrual.

scholarly journals Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) - study protocol of an open-label trial to investigate the mechanisms underlying the effects of a few-foods diet on ADHD symptoms in children

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029422 ◽  
Author(s):  
Tim Stobernack ◽  
Stefan P W de Vries ◽  
Rob Rodrigues Pereira ◽  
Lidy M Pelsser ◽  
Cajo J F ter Braak ◽  
...  
Keyword(s):  
Well Being ◽  
Adhd Symptoms ◽  
Long Term Effects ◽  
Open Label ◽  
Double Blind ◽  
Adhd Treatment ◽  
Open Label Trial ◽  
Biomarker Research ◽  
The Impact ◽  
Brain Study

IntroductionAttention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural disorder, causing significant impediment to a child’s development. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. Currently, treatment consists of behavioural and pharmacological therapy. However, ADHD medication is associated with several side effects, and concerns about long-term effects and efficacy exist. Therefore, there is considerable interest in the development of alternative treatment options. Double-blind research investigating the effects of a few-foods diet (FFD) has demonstrated a significant decrease in ADHD symptoms following an FFD. However, an FFD requires a considerable effort of both child and parents, limiting its applicability as a general ADHD treatment. To make FFD intervention less challenging or potentially obsolete, we need to understand how, and in which children, an FFD affects ADHD behaviour and, consequently, the child’s well-being. We hypothesise that an FFD affects brain function, and that the nutritional impact on ADHD is effectuated by a complex interplay between the microbiota, gut and brain, that is, the microbiota–gut–brain axis.Methods and analysisThe Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) study is an open-label trial with researchers blinded to changes in ADHD symptoms during sample processing and initial data analyses.Ethics and disseminationThe Medical Research and Ethics Committee of Wageningen University has approved this study (NL63851.081.17, application 17/24). Results will be disseminated through peer-reviewed journal publications, conference presentations, (social) media and the BRAIN study website. A summary of the findings will be provided to the participants.Trial registration numberNCT03440346.Study datesCollection of primary outcome data started in March 2018 and will be ongoing until 100 children have participated in the study. Sample data analysis will start after all samples have been collected.

PD26-10 TREATMENT OF HYPOGONADAL MEN WITH ORAL TESTOSTERONE UNDECANOATE (TU) IMPROVES PSYCHO-SEXUAL, WELL-BEING AND BODY COMPOSITION PARAMETERS

2020 ◽  
Vol 203 ◽  
pp. e547
Author(s):  
Stanton Honig* ◽  
Kaminetsky Jed ◽  
Marc Gittelman ◽  
Ronald Swerdloff ◽  
Theodore Danoff ◽  
...  
Keyword(s):  
Body Composition ◽  
Well Being ◽  
Testosterone Undecanoate

scholarly journals Novel Oral Testosterone Formulation Improves Male Well Being Without Compromising International Prostate Symptom Scores

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A760-A760
Author(s):  
Om P Dhingra ◽  
James Bernstein ◽  
Shaina D Barnes ◽  
Hannah VanLaanen ◽  
Natasha Wadlington ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Short Form ◽  
Controlled Trial ◽  
Group Versus ◽  
Well Being ◽  
Male Hypogonadism ◽  
Meaningful Improvement ◽  
Testosterone Undecanoate ◽  
Sf 36 ◽  
Patient Reported

Abstract Introduction: Male hypogonadism results from insufficient secretion of testosterone (T) and is characterized by low serum T concentrations. Common symptoms of hypogonadism include decreased libido, impotence, weakness, low energy, depression and/or loss of motivation, memory and concentrating issues, and sleep disturbances. Several forms of T replacement are available. Testosterone undecanoate (TU) is a testosterone prodrug available in oral formulations. A novel TU formulation, SOV2012-F1, has been submitted for FDA consideration under the name KYZATREX®. While TU efficacy is measured by serum total T, patientfocused endpoints such as Patient Reported Outcomes (PROs) are valuable indicators of well-being and psychosexual symptom abatement. Methods: A Phase 3, randomized, multicenter, open-label, active-controlled trial, comparing SOV2012F1 (testosterone undecanoate capsules) (n=214) with AndroGel® (1.62% topical testosterone gel) (n=100) enrolled males aged 18 to 65 years with hypogonadism (serum total T levels ≤281 ng/dL). A key exploratory endpoint was change from Baseline (ΔBL) after 52 weeks of treatment in the following PROs: International Prostate Symptom Score (IPSS), Psychosexual Daily Questionnaire (PDQ), Short Form Health Survey 36 item (SF-36), and the International Index of Erectile Function (IIEF). Results: Total or overall scores for all PROs (IPSS, PDQ, SF-36 and IIEF) showed increased improvement in the SOV2012-F1 group relative to the Androgel group, and all but IPSS demonstrated improvement relative to BL. For IPSS, due to the potential that T could worsen urinary symptoms, the ΔBL would ideally be small to reflect minimal impact. Change for the SOV2012-F1 and AndroGel groups was, respectively, 0.6 and 1.0. Further, the IPSS total score was not significantly different from BL in the patients receiving SOV20212-F1 (p = 0.5659). For PDQ, a clinically meaningful improvement of sexual desire in hypogonadal men age ≥65 years is ≥0.7; mean ΔBL was 1.6 in the SOV2012-F1 group versus 1.4 in the AndroGel group. In the SF-36, the mean ΔBL total score was 83.7 in the SOV2012-F1 group and 70.2 in the AndroGel group. Further, post hoc analysis of the Health Change category found a significant (p ≤ 0.05) improvement in patient perspectives on health over the course of the study. The overall satisfaction score of the IIEF trended towards significance for the SOV2012-F1 group with a mean ΔBL score of 2.3 versus and 1.6 in the AndroGel group. The ΔBL for the 4 domains of male sexual function were small and consistent between the SOV2012-F1 and AndroGel groups. Comparable results were noted for Early Withdrawals and All Subjects across all PROs. Conclusion: Treatment with SOV2012-F1 for 52 weeks exceeded AndroGel patient satisfaction as measured by PROs including IPSS, PDQ, SF-36 and IIEF, demonstrating clinical distinction. Further analysis of SOV2012-F1 will be forthcoming.

scholarly journals Serum and Urinary Osteocalcin in Healthy 7- to 19-Year-Old Finnish Children and Adolescents

2021 ◽  
Vol 9 ◽  
Author(s):  
Päivi M. Paldánius ◽  
Kaisa K. Ivaska ◽  
Outi Mäkitie ◽  
Heli Viljakainen
Keyword(s):  
Body Composition ◽  
Bone Turnover ◽  
Children And Adolescents ◽  
Bone Turnover Marker ◽  
High Growth ◽  
Reference Intervals ◽  
Normative Values ◽  
Specific Reference ◽  
Mineral Density ◽  
The Impact

Children and adolescents have high bone turnover marker (BTM) levels due to high growth velocity and rapid bone turnover. Pediatric normative values for BTMs reflecting bone formation and resorption are vital for timely assessment of healthy bone turnover, investigating skeletal diseases, or monitoring treatment outcomes. Optimally, clinically feasible measurement protocols for BTMs would be validated and measurable in both urine and serum. We aimed to (a) establish sex- and age-specific reference intervals for urinary and serum total and carboxylated osteocalcin (OC) in 7- to 19-year-old healthy Finnish children and adolescents (n = 172), (b) validate these against standardized serum and urinary BTMs, and (c) assess the impact of anthropometry, pubertal status, and body composition on the OC values. All OC values in addition to other BTMs increased with puberty and correlated with pubertal growth, which occurred and declined earlier in girls than in boys. The mean serum total and carboxylated OC and urinary OC values and percentiles for sex-specific age categories and pubertal stages were established. Correlation between serum and urinary OC was weak, especially in younger boys, but improved with increasing age. The independent determinants for OC varied, the urinary OC being the most robust while age, height, weight, and plasma parathyroid hormone (PTH) influenced serum total and carboxylated OC values. Body composition parameters had no influence on any of the OC values. In children and adolescents, circulating and urinary OC reflect more accurately growth status than bone mineral density (BMD) or body composition. Thus, validity of OC, similar to other BTMs, as a single marker of bone turnover, remains limited. Yet, serum and urinary OC similarly to other BTMs provide a valuable supplementary tool when assessing longitudinal changes in bone health with repeat measurements, in combination with other clinically relevant parameters.

Usefulness of the SF-36 Health Survey in Measuring Health Outcomes in the Depressed Elderly

1996 ◽  
Vol 9 (1) ◽  
pp. 13-21 ◽  
Author(s):  
Kathleen M. Beusterien ◽  
Bruce Steinwald ◽  
John E. Ware
Keyword(s):  
Mental Health ◽  
Health Survey ◽  
Rating Scale ◽  
Well Being ◽  
Clinical Severity ◽  
Functional Health ◽  
Sf 36 ◽  
The Impact ◽  
Health And Well Being ◽  
Over Time

Longitudinal data from a clinical trial were analyzed to evaluate the usefulness of the SF-36 Health Survey in estimating the impact of depression and changes in severity over time on the functional health and well-being of 532 patients, 60 to 86 years of age, who met DSM-III-R criteria for major depressive disorder. The Hamilton Depression Rating Scale, the Clinician's Global Impression of Severity and Improvement, and the Geriatric Depression Scale were used to define clinical severity and changes in severity over a 6-week period. Answers to SF-36 questions tended to be complete and to satisfy assumptions underlying methods of scale construction and scoring. As hypothesized, the SF-36 Mental Health Scale and Mental Component Summary measure, shown in previous studies to be most valid in measuring differences in mental health, exhibited the strongest associations with severity of depression in cross-sectional analyses and were most responsive to changes in severity in longitudinal comparisons. We conclude that the SF-36 Health Survey is useful for estimating the burden of depression and in monitoring changes in functional health and well-being over time among the depressed elderly.

scholarly journals The Effect of a Long-Term, Community-Based Exercise Program on Bone Mineral Density in Postmenopausal Women with Pre-Diabetes and Type 2 Diabetes

2014 ◽  
Vol 43 (1) ◽  
pp. 43-48 ◽  
Author(s):  
Marieni Bello ◽  
Maria Cirilo Sousa ◽  
Gabriel Neto ◽  
Leonardo Oliveira ◽  
Ialuska Guerras ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Type 2 Diabetes ◽  
Body Composition ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Exercise Program ◽  
Mineral Density ◽  
Community Based ◽  
The Impact

Abstract The aim of this study was to evaluate the impact of a community-based exercise program on bone mineral density and body composition in postmenopausal women with pre-diabetes and type 2 diabetes. Twenty postmenopausal women (aged 61.3 ± 6.0 years) with pre-diabetes and type 2 diabetes were randomly assigned to a community-based exercise program group (n=10) or a control group (n=10). The community-based exercise program was multicomponent, three days per week for 32 weeks, and included walking, resistance and aquatic exercises. Body composition and bone mineral density were measured pre and post-training by dual X-ray absorptiometry. In the exercise group significant increases were found in the ward’s triangle bone mineral density (+7.8%, p=0.043), and in fat-free mass (+2.4%, p=0.018). The findings suggest that regular multicomponent training is effective in preventing osteoporosis and sarcopenia among postmenopausal women with pre-diabetes and type 2 diabetes.

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