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

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

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 Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Device: Low-magnitude mechanical stimulation platform

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Amy D DiVasta, MD, MMSc, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: malnutrition; bone turnover; bone geometry; skeletal health
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 08-10-0461