Trial Outcomes & Findings for Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot) (NCT NCT02959853)
NCT ID: NCT02959853
Last Updated: 2020-01-30
Results Overview
Muscle strength was assessed using Biodex System 4 Isokinetic Dynamometer (Shirley, NY). Peak torque for isokinetic knee extension and flexion was measured at baseline, 6 months on the right leg. During the testing, participants sat with their hips flexed at 120 degrees, secured with thigh and pelvic straps. Testing was performed at an angular velocity of 60 degrees per second. The best result of 3 maximal voluntary efforts for each knee flexion and extension was used as the measure of absolute strength and reported as peak torque at 60 degrees in Newton-meter (N\*m) units. The higher the measured Newton-meter (N\*m), the greater the measured muscle strength.
COMPLETED
PHASE4
23 participants
baseline and 6 months
2020-01-30
Participant Flow
Participant milestones
| Measure |
Weight Loss Plus Placebo
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)
Baseline characteristics by cohort
| Measure |
Placebo Plus Weight Loss
n=11 Participants
Patients given a placebo and counseling on diet and exercise in order to achieve a goal weight loss of 10 percent.
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=12 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsMuscle strength was assessed using Biodex System 4 Isokinetic Dynamometer (Shirley, NY). Peak torque for isokinetic knee extension and flexion was measured at baseline, 6 months on the right leg. During the testing, participants sat with their hips flexed at 120 degrees, secured with thigh and pelvic straps. Testing was performed at an angular velocity of 60 degrees per second. The best result of 3 maximal voluntary efforts for each knee flexion and extension was used as the measure of absolute strength and reported as peak torque at 60 degrees in Newton-meter (N\*m) units. The higher the measured Newton-meter (N\*m), the greater the measured muscle strength.
Outcome measures
| Measure |
Weight Loss
n=7 Participants
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=10 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Percent Change in Muscle Strength as Assessed by Knee Extension and Knee Flexion
percent change in knee flexion
|
12.6 Percent change in muscle strength
Standard Deviation 13.3
|
8.9 Percent change in muscle strength
Standard Deviation 21.6
|
|
Percent Change in Muscle Strength as Assessed by Knee Extension and Knee Flexion
percent change in knee extension
|
12.8 Percent change in muscle strength
Standard Deviation 13.8
|
3.7 Percent change in muscle strength
Standard Deviation 14.7
|
PRIMARY outcome
Timeframe: baseline, 3 and 6 monthsSymptoms of androgen deficiency were measured with 3 validated questionnaires done at baseline, 3 and 6 months. 1. The Quantitative Androgen Deficiency in the Aging Male (qADAM) questionnaire uses questions from a scale of 1-5. The final summation yields a total score between 10 (most symptomatic) and 50 (least symptomatic). 2. The second questionnaire used was the International Index of Erectile Function (IIEF). Total score ranges from 5 to 25, with 5 being severe erectile dysfunction and 25 being no erectile dysfunction. 3. The third questionnaire used was the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL-lite). Total score ranges from 31 to 155, with 31 being least symptomatic and 155 being the most symptomatic. Score change at 3 months calculated by: total score at 3 months minus total score at baseline Score change at 6 months calculated by: total score at 6 months minus total score at baseline
Outcome measures
| Measure |
Weight Loss
n=7 Participants
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=10 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Change in Symptoms Score of Hypogonadism
qADAM score change at 3 months
|
2.4 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 3.4
|
5.8 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 6.1
|
|
Change in Symptoms Score of Hypogonadism
qADAM score change at 6 months
|
4.1 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 5.7
|
4.4 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 7.2
|
|
Change in Symptoms Score of Hypogonadism
IIEF score change at 3 monthss
|
4.3 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 3.8
|
2.7 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 4.6
|
|
Change in Symptoms Score of Hypogonadism
IIEF score change at 6 months
|
0.9 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 4.11
|
1.7 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 5.8
|
|
Change in Symptoms Score of Hypogonadism
IWQOL-lite score change at 3 month
|
-12.2 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 23.9
|
-13.0 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 15.2
|
|
Change in Symptoms Score of Hypogonadism
IWQOL-lite score change at 6 month
|
-16.6 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 27.1
|
-18.6 score on scale (qADAM, IIEF, IWQOL-lite)
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: baseline and 6 monthschange in fat was measured by Dual-energy X-ray absorptiometry (DXA) scan at baseline and 6 months only.
Outcome measures
| Measure |
Weight Loss
n=7 Participants
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=10 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Change in Fat Mass (in Kilograms)
|
-0.7 kilograms
Standard Deviation 1.9
|
-4.4 kilograms
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: baseline and 6 monthsChange in absolute visceral adipose tissue as measured by DXA scan, done at baseline and 6 months.
Outcome measures
| Measure |
Weight Loss
n=7 Participants
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=10 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Change in Visceral Adipose Tissue (in Grams)
|
28.9 grams
Standard Deviation 81.6
|
-111.7 grams
Standard Deviation 258.5
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPercent change in bone mineral density as measured by DXA scan, done at baseline and 6 months
Outcome measures
| Measure |
Weight Loss
n=7 Participants
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=10 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Percent Change in Bone Mineral Density
percent change in total hip bone density
|
-1.45 percent change
Standard Deviation 3.98
|
-0.46 percent change
Standard Deviation 2.66
|
|
Percent Change in Bone Mineral Density
percent change in femoral neck bone density
|
-1.63 percent change
Standard Deviation 2.92
|
0.82 percent change
Standard Deviation 3.83
|
|
Percent Change in Bone Mineral Density
percent change in lumbar spine bone density
|
3.22 percent change
Standard Deviation 4.89
|
-0.71 percent change
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPercent change in bone quality as measured by high resolution peripheral quantitative computed tomography scan (HR-pQCT), at baseline and 6 months
Outcome measures
| Measure |
Weight Loss
n=7 Participants
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=5 Participants
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Percent Change in Bone Quality
percent change in failure load at the radius
|
-2.16 percent change
Standard Deviation 3.09
|
-4.63 percent change
Standard Deviation 6.83
|
|
Percent Change in Bone Quality
percent change in bone stiffness at the radius
|
-2.09 percent change
Standard Deviation 3.29
|
-4.02 percent change
Standard Deviation 6.42
|
|
Percent Change in Bone Quality
percent change in failure load at the tibia
|
0.80 percent change
Standard Deviation 2.9
|
-0.81 percent change
Standard Deviation 4.62
|
|
Percent Change in Bone Quality
percent change in bone stiffness at the tibia
|
0.36 percent change
Standard Deviation 3.28
|
-1.31 percent change
Standard Deviation 5.17
|
Adverse Events
Weight Loss
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
Serious adverse events
| Measure |
Weight Loss
n=11 participants at risk
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=12 participants at risk
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Psychiatric disorders
Hospital admission
|
9.1%
1/11 • Number of events 1 • 2 years
see data tables
|
0.00%
0/12 • 2 years
see data tables
|
|
Musculoskeletal and connective tissue disorders
Hospital
|
0.00%
0/11 • 2 years
see data tables
|
8.3%
1/12 • Number of events 1 • 2 years
see data tables
|
Other adverse events
| Measure |
Weight Loss
n=11 participants at risk
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
weight loss
|
Aromatase Inhibitor (Anastrazole) Plus Weight Loss
n=12 participants at risk
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Anastrazole
weight loss
|
|---|---|---|
|
Endocrine disorders
Hot flashes
|
0.00%
0/11 • 2 years
see data tables
|
8.3%
1/12 • Number of events 1 • 2 years
see data tables
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/11 • 2 years
see data tables
|
8.3%
1/12 • Number of events 1 • 2 years
see data tables
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
9.1%
1/11 • Number of events 1 • 2 years
see data tables
|
0.00%
0/12 • 2 years
see data tables
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/11 • 2 years
see data tables
|
8.3%
1/12 • Number of events 1 • 2 years
see data tables
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/11 • 2 years
see data tables
|
8.3%
1/12 • Number of events 1 • 2 years
see data tables
|
|
Musculoskeletal and connective tissue disorders
heel pain
|
9.1%
1/11 • Number of events 1 • 2 years
see data tables
|
0.00%
0/12 • 2 years
see data tables
|
|
Endocrine disorders
uncontrolled DM
|
9.1%
1/11 • Number of events 1 • 2 years
see data tables
|
0.00%
0/12 • 2 years
see data tables
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/11 • 2 years
see data tables
|
8.3%
1/12 • Number of events 1 • 2 years
see data tables
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place