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| Name | Class |
|---|---|
| Tercica | INDUSTRY |
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The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.
Adolescents with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH. It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN. The physiologic effects of rhIGF-I treatment in adolescents with AN had not been studied. The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.
Specific Aim: It was hypothesized that adolescent AN patients, being IGF-I deficient, would respond to exogenously administered rhIGF-I with elevations in biochemical indices of bone turnover. Therefore, rhIGF-I was administered to AN patients by subcutaneous injection over 10 days with concomitant measurement of indices of bone turnover, and calcium regulatory hormones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin like growth factor- 1 (IGF-1) | Experimental | Adolescent girls with AN meeting inclusion criteria were administered recombinant human (rh) rhIGF-1 at a dose of 35-40 mcg/k twice daily by subcutaneous injections for a 7-10 day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhIGF-1 | Drug | 35-40 mcg/k/dose twice daily SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa | Baseline and 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa | Baseline and 7-10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhu Misra | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19523548 | Background | Misra M, McGrane J, Miller KK, Goldstein MA, Ebrahimi S, Weigel T, Klibanski A. Effects of rhIGF-1 administration on surrogate markers of bone turnover in adolescents with anorexia nervosa. Bone. 2009 Sep;45(3):493-8. doi: 10.1016/j.bone.2009.06.002. Epub 2009 Jun 10. |
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Four subjects were not interested in the study after the screen, and two were lost to follow-up.
Sixteen anorexia nervosa patients between the ages of 12-18 years were recruited. Patients were determined by their psychiatrists to meet criteria for AN as described in the Diagnostic and Statistical Manual of Mental Disorders (a).
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| ID | Title | Description |
|---|---|---|
| FG000 | RhIGF-1 | All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RhIGF-1 | All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa | 16 subjects were screened for the study, and 10 completed the study. 10 were analyzed. | Posted | Sep 2010 | Mean | Standard Error | ng/ml | Baseline and 7-10 days |
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One year
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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 | RhIGF-1 | All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for weight gain | Metabolism and nutrition disorders | Systematic Assessment | Not related to study or study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | General disorders | Systematic Assessment | Mild to moderate- not associated with raised intracranial pressure. Moderate: 3 subjects; two resolved with Tylenol or Advil Mild: 2 subjects; 1 resolved with Advil, the other did not need meds |
A limitation of our study is that this was not a randomized controlled trial of rhIGF-1 versus placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhu Misra, MD | Massachusetts General Hospital | 617-724-5602 | mmisra@partners.org |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000604197 | mecasermin |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa | Posted | Mean | Standard Error | ng/ml | Baseline and 7-10 days |
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| 1 |
| 16 |
| 4 |
| 16 |
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