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Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhIGF-1 followed by Risedronate | Active Comparator | Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly |
|
| Risedronate | Active Comparator | Risedronate 35mg PO once weekly for 12 months |
|
| Placebo | Placebo Comparator | Placebo for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhIGF-1 | Drug | Study participants will be started at a dose of 30 mcg/kg BID and will be titrated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postero-anterior Spine Bone Mineral Density by DXA | Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Lateral Spine Bone Mineral Density by DXA | Lateral spine bone mineral density by dual-energy X-ray absorptiometry | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Klibanski, MD | Massachusetts General Hospital | Principal Investigator |
| Erinne Meenaghan, NP | Massachusetts General Hospital | Study Chair |
| Karen Miller, MD | Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
148 subjects were consented and screened, 90 subjects were randomized, and 82 subjects completed the baseline visit. Of the 90 who were randomized, 8 subjects did not attend their scheduled baseline visits and did not receive study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | rhIGF-1 Followed by Risedronate | Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly |
| FG001 | Risedronate | Risedronate 35mg PO once weekly for 12 months |
| FG002 | Placebo | Placebo for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rhIGF-1 Followed by Risedronate | Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly |
| BG001 | Risedronate |
| 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 | Postero-anterior Spine Bone Mineral Density by DXA | Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry | Posted | Least Squares Mean | Standard Error | g/cm2 | 12 Months |
|
1 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 Followed by Risedronate | Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Irritation and/or Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event data collected at each study visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Klahr Miller | Massachusetts General Hospital | 6177263870 | kkmiller@mgh.harvard.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2019 | May 26, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2019 | Jul 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000604197 | mecasermin |
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Risedronate | Drug | Risedronate 35mg PO one time weekly |
|
|
| Placebo | Drug | Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly |
|
Risedronate 35mg PO once weekly for 12 months
| BG002 | Placebo | Placebo for 12 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Postero-anterior spine bone mineral density | Mean | Standard Deviation | g/cm2 |
|
| Lateral spine bone mineral density | Mean | Standard Deviation | g/cm2 |
|
Placebo for 12 months |
|
|
|
| Secondary | Lateral Spine Bone Mineral Density by DXA | Lateral spine bone mineral density by dual-energy X-ray absorptiometry | Posted | Least Squares Mean | Standard Error | g/cm2 | 12 Months |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 19 |
| 33 |
| EG001 | Risedronate | Risedronate 35mg PO once weekly for 12 months | 0 | 33 | 0 | 33 | 18 | 33 |
| EG002 | Placebo | Placebo for 12 months | 0 | 16 | 0 | 16 | 5 | 16 |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Upset Stomach | Gastrointestinal disorders | Systematic Assessment |
|
| Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Achiness | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Superiority |