Trial Outcomes & Findings for Testosterone and Growth Hormone for Bone Loss in Men (NCT NCT00080483)
NCT ID: NCT00080483
Last Updated: 2014-06-13
Results Overview
Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
baseline, one year, two years
Results posted on
2014-06-13
Participant Flow
This study was initiated in December, 2004 and enrollment ended in September 2008. Forty nine subjects were screened; 14 were screen failures and 35 subjects were randomized. Four subjects were withdrawn and 31 subjects completed the study.
Participant milestones
| Measure |
1Testosterone Only
Testosterone transdermally 5 g a day
|
2Testosterone Plus Growth Hormone
AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
1Testosterone Only
Testosterone transdermally 5 g a day
|
2Testosterone Plus Growth Hormone
AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Testosterone and Growth Hormone for Bone Loss in Men
Baseline characteristics by cohort
| Measure |
1Testosterone Only
n=17 Participants
Testosterone transdermally 5 g a day
|
2Testosterone Plus Growth Hormone
n=18 Participants
AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
|
Total
n=35 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
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 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
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
18 participants
n=107 Participants
|
35 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, one year, two yearsPopulation: All subjects who had both baseline and one year evaluations
Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia
Outcome measures
| Measure |
2 The Effects of Testosterone Alone on Structural and Mechanic
n=15 Participants
AndroGel transdermally 5 g a day for two years
testosterone: AndroGel transdermally 5 g a day for two years
|
1 The Effects of Testosterone Combined With G
n=17 Participants
AndroGel transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day
AndroGel plus somatropin: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
|
|---|---|---|
|
MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
baseline
|
0.104 unitless
Standard Error 0.004
|
0.112 unitless
Standard Error 0.004
|
|
MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
one year
|
0.111 unitless
Standard Error 0.006
|
0.119 unitless
Standard Error 0.004
|
|
MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
two years
|
0.114 unitless
Standard Error 0.005
|
0.123 unitless
Standard Error 0.005
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
1Testosterone Only
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
2Testosterone Plus Growth Hormone
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1Testosterone Only
n=17 participants at risk
Testosterone transdermally 5 g a day
|
2Testosterone Plus Growth Hormone
n=18 participants at risk
AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
|
|---|---|---|
|
Gastrointestinal disorders
cholycystitis
|
5.9%
1/17 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
0.00%
0/18
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Cardiac disorders
coronary artery disease
|
5.9%
1/17 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
0.00%
0/18
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Nervous system disorders
sellar mass
|
5.9%
1/17 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
5.6%
1/18 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Nervous system disorders
memory loss
|
5.9%
1/17 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
0.00%
0/18
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Musculoskeletal and connective tissue disorders
arthritis of knee
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
5.6%
1/18 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Musculoskeletal and connective tissue disorders
fracture
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
5.6%
1/18 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Reproductive system and breast disorders
cancer of prostate
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
5.6%
1/18 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
Other adverse events
| Measure |
1Testosterone Only
n=17 participants at risk
Testosterone transdermally 5 g a day
|
2Testosterone Plus Growth Hormone
n=18 participants at risk
AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
|
|---|---|---|
|
General disorders
fatigue
|
5.9%
1/17 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
11.1%
2/18 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
11.1%
2/18 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Cardiac disorders
increase in blood pressure
|
5.9%
1/17 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
5.6%
1/18 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Infections and infestations
tooth infection
|
11.8%
2/17 • Number of events 4
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
0.00%
0/18
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Endocrine disorders
hypothyroid
|
11.8%
2/17 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
16.7%
3/18 • Number of events 3
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Gastrointestinal disorders
constipation
|
11.8%
2/17 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
5.6%
1/18 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Gastrointestinal disorders
nausea
|
11.8%
2/17 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
0.00%
0/18
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
38.9%
7/18 • Number of events 9
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Blood and lymphatic system disorders
anemia
|
11.8%
2/17 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
16.7%
3/18 • Number of events 3
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Reproductive system and breast disorders
elevated PSA
|
5.9%
1/17 • Number of events 1
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
16.7%
3/18 • Number of events 3
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Nervous system disorders
positive Tinnel's sign
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
22.2%
4/18 • Number of events 4
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Nervous system disorders
headache
|
0.00%
0/17
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
11.1%
2/18 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
|
Renal and urinary disorders
urinary tract infection
|
11.8%
2/17 • Number of events 2
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
0.00%
0/18
Adverse events were reported for the 32 subjects who completed one or more years of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place