Anorexia Nervosa, Eating Disorders, Osteopenia, Osteoporosis
Conditions
Keywords
Anorexia Nervosa, Eating disorder, Bone, Growth hormone, Osteopenia, Osteoporosis
Brief summary
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength. We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.
Detailed description
* Twelve week study * Eight visits, six of which can be conducted at your home physician's office * Two bone density scans * Hormonal and nutritional evaluations
Interventions
DRUGRecombinant Human Growth Hormone
Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
DRUGPlacebo for Recombinant Human Growth Hormone
Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
Sponsors
Genentech, Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* women between 14 to 45 years with anorexia nervosa
Exclusion criteria
* pregnancy * previous history of malignancy. * oral contraceptive pills or other hormones within last 8 - 12 weeks * medications known to affect bone within last 12 weeks * fracture within last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Metabolism | Baseline, 12 weeks | Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 Level | Baseline, 12 Weeks | Change in IGF-1 level between baseline and 12 weeks |
Countries
United States
Participant flow
Recruitment details
Subjects were referred from by local eating disorders providers and were recruited from on-line advertisements. Recruitment period: April 2006 through November 2008.
Participants by arm
| Arm | Count |
|---|---|
| Recombinant Human Growth Hormone Group Treatment with rHGH | 10 |
| Placebo Group Treatment with Placebo | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Recombinant Human Growth Hormone Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 28.0 years STANDARD_DEVIATION 6.7 | 29.2 years STANDARD_DEVIATION 8.6 | 28.7 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 10 | 9 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
Bone Metabolism
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
Time frame: Baseline, 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recombinant Human Growth Hormone Group | Bone Metabolism | 34.3 ng/ml | Standard Error 16.7 |
| Placebo Group | Bone Metabolism | 10.4 ng/ml | Standard Error 7.1 |
Secondary
IGF-1 Level
Change in IGF-1 level between baseline and 12 weeks
Time frame: Baseline, 12 Weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Recombinant Human Growth Hormone Group | IGF-1 Level | 6.5 ng/ml |
| Placebo Group | IGF-1 Level | 10 ng/ml |