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| ID | Type | Description | Link |
|---|---|---|---|
| CDER |
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Adolescents and young adults 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 1 (IGF-1), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of insulin-like growth factor 1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents and young adults with anorexia nervosa have not been studied. The goal of this proposal is to investigate the effects of recombinant human insulin-like growth factor 1 on bone density and bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a 6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients, being insulin-like growth factor 1 deficient, will respond to exogenously administered recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure, or maintain bone density (in contrast to the decrease in bone density expected in adolescent girls and women with anorexia nervosa who are not treated).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anorexia Nervosa Females | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human insulin like growth factor-1 (rhIGF-1) | Drug | Twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spine Bone Density (g/cm^2) | Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated. | Baseline and 6 months |
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Inclusion Criteria:
- Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhusmita Misra, MD | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anorexia Nervosa Females | Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anorexia Nervosa Females | Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously |
| 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 Spine Bone Density (g/cm^2) | Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated. | The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol. | Posted | Nov 2011 | Mean | Standard Error | gm/cm^2 | Baseline and 6 months |
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For the adolescent arm, adverse event data was collected for 6 months. For the adult arm, adverse event data was collected for 1 year.
All subjects were assessed for any adverse events at screen, baseline, 1 month, 3 months, 4.5 months, and 6 months. The adult arm was subsequently assessed for any adverse events at 7 months, 9 months, and 12 months.
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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 | Anorexia Nervosa Females | Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | These are unrelated and expected Serious Adverse Events and are due to the subjects' eating disorders. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itchiness at Injection Site | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhusmita Misra, M.D., Associate Professor in Pediatrics, Assistant Pediatrician | 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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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| 5 |
| 28 |
| 22 |
| 28 |
|
| Self-Injury | General disorders | Systematic Assessment | This is an unrelated and expected Serious Adverse Event and is due to this subject's eating disorder and depression. |
|
| Facial Discoloration | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment | Subject fell while running for bus and suffered abrasions on left knee, shin, foot and hand. |
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| Food Poisoning | Gastrointestinal disorders | Systematic Assessment | Subject ate hummus and felt ill afterwards. |
|
| Elevated Aspartate Aminotransferase | General disorders | Systematic Assessment |
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| Severe Weight Loss | General disorders | Systematic Assessment | Subject exhibited severe weight loss at 9 month study visit and was discontinued from study due to refusal of inpatient treatment, for safety reasons. |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | Subject stated it could be due to fatty food recently eaten. |
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| Femoral Lymph Node Enlargement | General disorders | Systematic Assessment | Subject reported this, but enlargement was not found on exam by study nurse practitioner. |
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| Bruising | General disorders | Systematic Assessment | One subject said this was due to her eating disorder and did not occur specifically at the injection site. |
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| Cold with Mild Nose Bleed | General disorders | Systematic Assessment |
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| Lightheaded and Pale at Blood Draw | General disorders | Systematic Assessment |
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| Low Glucose Level | General disorders | Systematic Assessment |
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| Elevated Alanine Aminotransferase | General disorders | Systematic Assessment |
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| Heartburn | General disorders | Systematic Assessment | One subject said that this was due to her calcium supplements. |
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| Achiness | General disorders | Systematic Assessment |
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| Spider Bite | General disorders | Systematic Assessment |
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| Mild Itchiness to Bilateral Lower Extremities | General disorders | Systematic Assessment | The subject stated that this was most likely due to her recent change in soap powder. |
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| Breast Bone Pain | General disorders | Systematic Assessment | The subject reported the pain lasting 5 -6 seconds and then resolving spontaneously. |
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| Dizziness | General disorders | Systematic Assessment | Coincided with the subject's recent Lexapro dose reduction. |
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| Soreness at Injection Site | General disorders | Systematic Assessment |
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| Low Potassium Level | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
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| Increased Fatigue | General disorders | Systematic Assessment | Coincided with subject's increase in Prozac dosage. |
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| Irritation at Injection Site | General disorders | Systematic Assessment |
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| Papules at Injection Site | General disorders | Systematic Assessment |
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| Abdominal Bloating | General disorders | Systematic Assessment |
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| Burning Sensation at Injection Site | General disorders | Systematic Assessment |
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| Poison Ivy Rash | General disorders | Systematic Assessment |
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| Prominent Thyroid | General disorders | Systematic Assessment | The subject did not have a goiter. Her thyroid stimulating hormone, thyroxine, and triiodothyronine labs were all normal. |
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| Swelling of Bilateral Feet | General disorders | Systematic Assessment | Subject stated that this was probably due to warm weather. |
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| Night Sweats | General disorders | Systematic Assessment | Subject stated that this was mostly likely due to warmer weather and the temperature being higher in her apartment building. |
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| Back Pain | General disorders | Systematic Assessment | Subject had an ongoing history of back pain. |
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| Joint Pain | General disorders | Systematic Assessment | In subject's hand. |
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| Hip Pain | General disorders | Systematic Assessment |
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| Headaches | General disorders | Systematic Assessment | The subject had an ongoing history of headaches. |
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| Erythema at Injection Site | General disorders | Systematic Assessment |
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| Elevated Insulin-like Growth Factor 1 | General disorders | Systematic Assessment |
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| Elevated Potassium Level | General disorders | Systematic Assessment |
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| Extremity Pain | General disorders | Systematic Assessment | Subject felt pain in hand and wrist after school and occasionally during school. |
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| Occasional Bleeding at Injection Site | General disorders | Systematic Assessment |
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| Kidney Stone | Renal and urinary disorders | Systematic Assessment | Subject had a kidney stone that pass and was not tested. Subject followed up with a specialist and stopped taking calcium supplements. |
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