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| Name | Class |
|---|---|
| Kessler Institute for Rehabilitation | INDUSTRY |
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It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:
body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.
Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone Replacement Therapy | Experimental | Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch) |
|
| No Intervention | No Intervention | Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Transdermal System (Androderm 5 mg patch) | Drug | Testosterone Transdermal System (Androderm 5 mg patch) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) | Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the "on-and-off -the-table" method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Energy Expenditure | Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Bauman, MD | VA Medical Center, Bronx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States | ||
| James J. Peters VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21717386 | Result | Bauman WA, Cirnigliaro CM, La Fountaine MF, Jensen AM, Wecht JM, Kirshblum SC, Spungen AM. A small-scale clinical trial to determine the safety and efficacy of testosterone replacement therapy in hypogonadal men with spinal cord injury. Horm Metab Res. 2011 Jul;43(8):574-9. doi: 10.1055/s-0031-1280797. Epub 2011 Jun 29. | |
| 21252493 |
| Label | URL |
|---|---|
| Click here for more information about this study: Testosterone Replacement Therapy in Chronic Spinal Cord Injury | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Replacement Therapy | Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. |
| FG001 | No Intervention | Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Replacement Therapy | Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch) |
| BG001 | No Intervention | Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM) | Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the "on-and-off -the-table" method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM. | Posted | Mean | Standard Deviation | kilograms | 12 months |
|
Adverse events from this study were collected over a 12-month period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone Replacement Therapy | A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | Autonomic dysreflexia due to urinary tract infection followed by hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Minor skin irritation at patch site definitely related to testosterone replacement therapy |
Compared to similar trials our trial was relatively small. Although there was statistical and clinical changes associated with testosterone replacement therapy, the translation of these findings with regard to functional gain was not addressed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William A. Bauman, M.D. | James J. Peters VA Medical Center | 718-584-9000 | 5428 | william.bauman@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D057968 | Transdermal Patch |
| D043343 | Testosterone Propionate |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 12 months |
| The Bronx |
| New York |
| 10468 |
| United States |
| La Fountaine MF, Wecht JM, Cirnigliaro CM, Kirshblum SC, Spungen AM, Bauman WA. QT/RR coherence is associated with testosterone levels in men with chronic spinal cord injury. Neuroendocrinology. 2011;93(3):174-80. doi: 10.1159/000323773. Epub 2011 Jan 21. |
| 23343764 | Result | La Fountaine MF, Wecht JM, Cirnigliaro CM, Kirshblum SC, Spungen AM, Bauman WA. Testosterone replacement therapy improves QTaVI in hypogonadal men with spinal cord injury. Neuroendocrinology. 2013;97(4):341-6. doi: 10.1159/000347070. Epub 2013 May 9. |
| 24968251 | Derived | Bauman WA, La Fountaine MF, Cirnigliaro CM, Kirshblum SC, Spungen AM. Lean tissue mass and energy expenditure are retained in hypogonadal men with spinal cord injury after discontinuation of testosterone replacement therapy. J Spinal Cord Med. 2015 Jan;38(1):38-47. doi: 10.1179/2045772314Y.0000000206. Epub 2014 Jun 26. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Hypogonadal (Testosterone Replacement Therapy group, total testosterone < 4 ng/ml) and Eugonadal (No Intervention group total testosterone > 4 ng/ml) subjects | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Dual energy x-ray absorptiometry (DXA) for lean tissue mass | Body composition measurements for measures of total body lean tissue mass (LTM) were assessed by dual energy X-ray absorptiometry (DXA; General Electric LUNAR Prodigy Advance, software version 11.4 and 12.2, Madison, WI). In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the "on-and-off -the-table" method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM. | Mean | Standard Deviation | kilograms |
|
| Resting Energy Expenditure | Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions and was adjusted to account for differences in total body lean tissue mass. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12 hour fast, with a minimum of 24 hours free from any type of exercise. | Mean | Standard Deviation | kcal/day |
|
| OG001 | No Intervention | Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points. |
|
|
|
| Secondary | Resting Energy Expenditure | Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise. | Posted | Mean | Standard Deviation | kcal/day | 12 months |
|
|
|
|
| 1 |
| 18 |
| 11 |
| 18 |
|
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment | minor body acne probably related to testosterone replacement therapy |
|
| Edema | Blood and lymphatic system disorders | Non-systematic Assessment | Increase in lower extremity edema possibly related to testosterone replacement therapy |
|
| Elevated hemoglobin and hematocrit | Blood and lymphatic system disorders | Non-systematic Assessment | Slight elevation of hemoglobin and hematocrit levels from testosterone replacement therapy |
|
| Liver function enzymes | Hepatobiliary disorders | Non-systematic Assessment | Elevated liver function enzymes possibly related to testosterone replacement therapy |
|
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| D014947 | Wounds and Injuries |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004864 | Equipment and Supplies |