Trial Outcomes & Findings for Testosterone Replacement Therapy in Chronic Spinal Cord Injury (NCT NCT00266864)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

31 participants

Primary outcome timeframe

12 months

Results posted on

2017-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	18	13
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone Replacement Therapy n=13 Participants Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)	No Intervention n=11 Participants Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Male	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants
Dual energy x-ray absorptiometry (DXA) for lean tissue mass	49.6 kilograms STANDARD_DEVIATION 7.6 • n=5 Participants	51.9 kilograms STANDARD_DEVIATION 8.1 • n=7 Participants	50.8 kilograms STANDARD_DEVIATION 7.8 • n=5 Participants
Resting Energy Expenditure	1328 kcal/day STANDARD_DEVIATION 262 • n=5 Participants	1319 kcal/day STANDARD_DEVIATION 112 • n=7 Participants	1324 kcal/day STANDARD_DEVIATION 197 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Testosterone Replacement Therapy n=13 Participants 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.	No Intervention n=11 Participants 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.
Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)	53.1 kilograms Standard Deviation 6.9	50.5 kilograms Standard Deviation 6.3

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Testosterone Replacement Therapy n=13 Participants 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.	No Intervention n=11 Participants 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.
Resting Energy Expenditure	1440 kcal/day Standard Deviation 262	1339 kcal/day Standard Deviation 128

Adverse Events

Testosterone Replacement Therapy

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Testosterone Replacement Therapy n=18 participants at risk 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.
Renal and urinary disorders Urinary tract infection	5.6% 1/18 • Number of events 1 • Adverse events from this study were collected over a 12-month period

Other adverse events

Other adverse events
Measure	Testosterone Replacement Therapy n=18 participants at risk 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.
Skin and subcutaneous tissue disorders Skin irritation	61.1% 11/18 • Number of events 11 • Adverse events from this study were collected over a 12-month period
Skin and subcutaneous tissue disorders Acne	5.6% 1/18 • Number of events 1 • Adverse events from this study were collected over a 12-month period
Blood and lymphatic system disorders Edema	22.2% 4/18 • Number of events 4 • Adverse events from this study were collected over a 12-month period
Blood and lymphatic system disorders Elevated hemoglobin and hematocrit	5.6% 1/18 • Number of events 1 • Adverse events from this study were collected over a 12-month period
Hepatobiliary disorders Liver function enzymes	5.6% 1/18 • Number of events 1 • Adverse events from this study were collected over a 12-month period

Additional Information

William A. Bauman, M.D.

James J. Peters VA Medical Center

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place