Trial Outcomes & Findings for Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa (NCT NCT00283595)
NCT ID: NCT00283595
Last Updated: 2020-09-02
Results Overview
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
COMPLETED
PHASE2
21 participants
Baseline, 12 weeks
2020-09-02
Participant Flow
Subjects were referred from by local eating disorders providers and were recruited from on-line advertisements. Recruitment period: April 2006 through November 2008.
Participant milestones
| Measure |
Recombinant Human Growth Hormone(Subcutaneous Daily Injection)
Treatment with rHGH
|
Placebo (Subcutaneous Daily Injection)
Treatment with Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Recombinant Human Growth Hormone(Subcutaneous Daily Injection)
Treatment with rHGH
|
Placebo (Subcutaneous Daily Injection)
Treatment with Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
Recombinant Human Growth Hormone Group
n=10 Participants
Treatment with rHGH
|
Placebo Group
n=11 Participants
Treatment with Placebo
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
29.2 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
28.7 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Only subjects who completed study visits after the baseline visit were included in the analysis. The three subjects who discontinued the study only completed a baseline visit and were therefore not included in the analysis.
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
Outcome measures
| Measure |
Recombinant Human Growth Hormone Group
n=9 Participants
Treatment with rHGH
|
Placebo Group
n=9 Participants
Treatment with Placebo
|
|---|---|---|
|
Bone Metabolism
|
34.3 ng/ml
Standard Error 16.7
|
10.4 ng/ml
Standard Error 7.1
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: The analysis group consisted of individuals who completed study visits after the baseline visit. The three subjects who did not continue in the study discontinued their participation after the baseline visit.
Change in IGF-1 level between baseline and 12 weeks
Outcome measures
| Measure |
Recombinant Human Growth Hormone Group
n=9 Participants
Treatment with rHGH
|
Placebo Group
n=9 Participants
Treatment with Placebo
|
|---|---|---|
|
IGF-1 Level
|
6.5 ng/ml
Interval -23.3 to 66.5
|
10 ng/ml
Interval -16.3 to 32.0
|
Adverse Events
Recombinant Human Growth Hormone Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recombinant Human Growth Hormone Group
n=10 participants at risk
Treatment with rHGH
|
Placebo Group
n=11 participants at risk
Treatment with Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 4
|
45.5%
5/11 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
20.0%
2/10 • Number of events 4
|
18.2%
2/11 • Number of events 3
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 9
|
36.4%
4/11 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
2/10 • Number of events 2
|
36.4%
4/11 • Number of events 7
|
|
General disorders
Edema
|
40.0%
4/10 • Number of events 4
|
9.1%
1/11 • Number of events 2
|
|
General disorders
Lightheadedness
|
30.0%
3/10 • Number of events 6
|
45.5%
5/11 • Number of events 7
|
|
Endocrine disorders
Polyuria
|
20.0%
2/10 • Number of events 2
|
0.00%
0/11
|
|
Psychiatric disorders
Depressive symptoms
|
20.0%
2/10 • Number of events 2
|
36.4%
4/11 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 6
|
27.3%
3/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Irritation at injection site
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 4
|
|
Eye disorders
Blurry vision
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Paresthesias (carpal tunnel symptoms)
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
|
18.2%
2/11 • Number of events 3
|
|
General disorders
Cold intolerance
|
0.00%
0/10
|
27.3%
3/11 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Polydypsia
|
0.00%
0/10
|
9.1%
1/11 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place