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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength 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 -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.
Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a number of significant medical conditions including bone loss. A majority of women with anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2 standard deviations below normative means. Bone loss in anorexia nervosa is characterized by a decrease in bone formation, therefore therapy with an anabolic agent may be an effective treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density (primary outcome).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | sc daily for 6 months |
| |
| Teriparatide |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Lumbar Spine Bone Mineral Density | Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period) | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pouneh K Fazeli, MD | Massachusetts General Hospital | 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 | Teriparatide | Teriparatide: Teriparatide 20 mcg sc daily for 6 months |
| FG001 | Placebo | Placebo: Placebo 20 mcg sc daily for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide | Teriparatide: Teriparatide 20 mcg sc daily for 6 months |
| BG001 | Placebo | Placebo: Placebo 20 mcg sc daily for 6 months |
| 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 | Percent Change in Lumbar Spine Bone Mineral Density | Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period) | All participants were included in analysis (intention to treat). | Posted | Mean | Standard Error | percentage of change | Baseline and 6 months |
|
6 months
Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
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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 | Teriparatide | Teriparatide: Teriparatide 20 mcg sc daily for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization or exacerbation | Psychiatric disorders | Non-systematic Assessment | Subjects hospitalized (or had worsening of) anorexia nervosa-related complications (all were considered unrelated to study drug) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pouneh K. Fazeli, MD | Massachusetts General Hospital | 617-726-3870 | pkfazeli@partners.org |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Drug |
20 mcg sc daily for 6 months |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 2 |
| 12 |
| 12 |
| 12 |
| EG001 | Placebo | Placebo: Placebo 20 mcg sc daily for 6 months | 3 | 11 | 9 | 12 |
|
| Muscle pain/spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Injection site ecchymoses, bruising, erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated serum calcium | Endocrine disorders | Systematic Assessment |
|
| Elevated 24hr urine calcium | Endocrine disorders | Systematic Assessment |
|
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| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |