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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo platform | Placebo Comparator | Randomized to stand on placebo platform for 10 minutes/day |
|
| Low-magnitude mechanical stimulation | Active Comparator | Randomized to stand on LMMS platform 10 minutes/daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-magnitude mechanical stimulation platform | Device | Low-magnitude mechanical stimulation platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in C-telopeptides | Baseline to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bone Specific Alkaline Phosphatase | baseline to 5 days |
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Inclusion Criteria:
Exclusion Criteria:
• Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus
Use of medications known to affect bone metabolism in the last 3 months, such as:
Depot medroxyprogesterone (Depo-Provera) use in the last 12 months
Current pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Amy D DiVasta, MD, MMSc | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39480424 | Derived | DiVasta AD, Stamoulis C, Rubin CT, Gallagher JS, Kiel DP, Snyder BD, Gordon CM. Low-Magnitude Mechanical Signals to Preserve Skeletal Health in Female Adolescents With Anorexia Nervosa: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2441779. doi: 10.1001/jamanetworkopen.2024.41779. | |
| 38504970 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | LMMS | Randomized to 10 min LMMS daily |
| FG001 | Placebo | Randomized to sham platform 10 min daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LMMS | Randomized to 10 min LMMS daily |
| BG001 | Placebo | Randomized to sham platform 10 min daily |
| 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 | Change From Baseline in C-telopeptides | Posted | Mean | 95% Confidence Interval | ng/mL/day | Baseline to 5 days |
|
|
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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 | LMMS | Randomized to 10 min LMMS daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy DiVasta, PI | Boston Children's Hospital | 6173553792 | amy.divasta@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Lin JA, Stamoulis C, DiVasta AD. Associations between nutritional intake, stress and hunger biomarkers, and anxiety and depression during the treatment of anorexia nervosa in adolescents and young adults. Eat Behav. 2023 Dec;51:101822. doi: 10.1016/j.eatbeh.2023.101822. Epub 2023 Oct 26. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Deemed ineligible after consent |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI Z-score | Mean | Standard Deviation | Z-score |
|
|
| Secondary | Change From Baseline in Bone Specific Alkaline Phosphatase | Posted | Mean | 95% Confidence Interval | ug/L/day | baseline to 5 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Randomized to sham platform 10 min daily | 0 | 21 | 0 | 21 |
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