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

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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

April 7, 2010
April 9, 2010
November 29, 2016
May 17, 2017
May 17, 2017
April 2009
May 2015   (Final data collection date for primary outcome measure)
Change From Baseline in C-telopeptides [ Time Frame: Baseline to 5 days ]
pQCT measures of bone geometry [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01100567 on ClinicalTrials.gov Archive Site
Change From Baseline in Bone Specific Alkaline Phosphatase [ Time Frame: baseline to 5 days ]
Bone turnover markers [ Time Frame: q 3 months ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Anorexia Nervosa
Device: Low-magnitude mechanical stimulation platform
Low-magnitude mechanical stimulation platform
  • Placebo Comparator: Placebo platform
    Randomized to stand on placebo platform for 10 minutes/day
    Intervention: Device: Low-magnitude mechanical stimulation platform
  • Active Comparator: Low-magnitude mechanical stimulation
    Randomized to stand on LMMS platform 10 minutes/daily
    Intervention: Device: Low-magnitude mechanical stimulation platform
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
50
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
11 Years to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01100567
08-10-0461
No
Not Provided
Not Provided
Amy DiVasta, Boston Children’s Hospital
Boston Children’s Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Amy D DiVasta, MD, MMSc Boston Children’s Hospital
Boston Children’s Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP