Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa

Study Overview
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Brief Summary
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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.

Official Title
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EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Device: Low-magnitude mechanical stimulation platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 11-25 years Diagnosis of anorexia nervosa based on DSM-IV criteria Female gender English-speaking 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: Glucocorticoid therapy (including inhaled steroids) Anticonvulsants Combined estrogen/progestin contraceptive agents (oral contraceptive pills) Depot medroxyprogesterone (Depo-Provera) use in the last 12 months Current pregnancy

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo platform<br>Randomized to stand on placebo platform for 10 minutes/day | Device: Low-magnitude mechanical stimulation platform<br>* Low-magnitude mechanical stimulation platform<br>|
| Active Comparator: Low-magnitude mechanical stimulation<br>Randomized to stand on LMMS platform 10 minutes/daily | Device: Low-magnitude mechanical stimulation platform<br>* Low-magnitude mechanical stimulation platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in C-telopeptides |  | Baseline to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Bone Specific Alkaline Phosphatase |  | baseline to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skeletal health, bone turnover, bone geometry, malnutrition