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

Boston Children's Hospital101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

101

Conditions

Anorexia Nervosa

Interventions

Low-magnitude mechanical stimulation platform

Eligibility

Sex: FEMALEMin age: 11 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in C-telopeptides

Time frame: Baseline to 5 days

Secondary Outcomes

Change From Baseline in Bone Specific Alkaline Phosphatase

Time frame: baseline to 5 days