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

This study has been completed.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Amy DiVasta, Children's Hospital Boston Identifier:
First received: April 7, 2010
Last updated: August 5, 2015
Last verified: August 2015
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

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 ]

Enrollment: 51
Study Start Date: April 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (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


Ages Eligible for Study:   11 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01100567

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Amy D DiVasta, MD, MMSc Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Amy DiVasta, Principal Investigator, Children's Hospital Boston Identifier: NCT01100567     History of Changes
Other Study ID Numbers: 08-10-0461
Study First Received: April 7, 2010
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anorexia Nervosa
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on November 27, 2015