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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01100567
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Amy DiVasta, Boston Children’s Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Anorexia Nervosa Device: Low-magnitude mechanical stimulation platform Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
Study Start Date : April 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in C-telopeptides [ Time Frame: Baseline to 5 days ]

Secondary Outcome Measures :
  1. Change From Baseline in Bone Specific Alkaline Phosphatase [ Time Frame: baseline to 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   11 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100567


Locations
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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Amy D DiVasta, MD, MMSc Boston Children’s Hospital
More Information
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Responsible Party: Amy DiVasta, Principal Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01100567    
Other Study ID Numbers: 08-10-0461
First Posted: April 9, 2010    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: April 2017
Keywords provided by Amy DiVasta, Boston Children’s Hospital:
skeletal health
bone turnover
bone geometry
malnutrition
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
 Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders