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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment with rHGH |
|
| 2 | Placebo Comparator | Treatment with Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Growth Hormone | Drug | Dosage increased in steps for first four weeks. Self injection qd x 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Metabolism | Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 Level | Change in IGF-1 level between baseline and 12 weeks | Baseline, 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Klibanski, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusettes General Hospital | Boston | Massachusetts | 02114 | United States |
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Subjects were referred from by local eating disorders providers and were recruited from on-line advertisements. Recruitment period: April 2006 through November 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Human Growth Hormone(Subcutaneous Daily Injection) | Treatment with rHGH |
| FG001 | Placebo (Subcutaneous Daily Injection) | Treatment with Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recombinant Human Growth Hormone Group | Treatment with rHGH |
| BG001 | Placebo Group | Treatment with Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Error | ng/ml | Baseline, 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Human Growth Hormone Group | Treatment with rHGH |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Klibanski, MD | Massachusetts General Hospital | 617-726-3870 | aklibanski@partners.org |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo for Recombinant Human Growth Hormone | Drug | Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | IGF-1 Level | Change in IGF-1 level between baseline and 12 weeks | 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. | Posted | Median | Inter-Quartile Range | ng/ml | Baseline, 12 Weeks |
|
|
|
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | Placebo Group | Treatment with Placebo | 0 | 11 | 9 | 11 |
| Arthralgias | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Edema | General disorders |
|
| Lightheadedness | General disorders |
|
| Polyuria | Endocrine disorders |
|
| Depressive symptoms | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Irritation at injection site | Skin and subcutaneous tissue disorders |
|
| Blurry vision | Eye disorders |
|
| Paresthesias (carpal tunnel symptoms) | Musculoskeletal and connective tissue disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Cold intolerance | General disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Polydypsia | General disorders |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |