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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014