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

This study is currently recruiting participants.
Verified June 2011 by Children's Hospital Boston
Sponsor:
Collaborator:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01100567
First received: April 7, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Anorexia Nervosa
Device: Low-magnitude mechanical stimulation platform

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • pQCT measures of bone geometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone turnover markers [ Time Frame: q 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 22 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 13-22 years, at least two years post-menarche
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100567

Contacts
Contact: Amy D DiVasta, MD, MMSc 6173553792 amy.divasta@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Amy D DiVasta, MD, MMSc    617-355-3792    amy.divasta@childrens.harvard.edu   
Principal Investigator: Amy D DiVasta, MD, MMSc         
Sponsors and Collaborators
Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Amy DiVasta, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01100567     History of Changes
Other Study ID Numbers: 08-10-0461
Study First Received: April 7, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
skeletal health
bone turnover
bone geometry
malnutrition

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014