NCT01100567
Completed
Not Applicable
EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
ConditionsAnorexia Nervosa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anorexia Nervosa
- Sponsor
- Boston Children's Hospital
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Change From Baseline in C-telopeptides
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Amy DiVasta
Principal Investigator
Boston Children's Hospital
Eligibility 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
Outcomes
Primary Outcomes
Change From Baseline in C-telopeptides
Time Frame: Baseline to 5 days
Secondary Outcomes
- Change From Baseline in Bone Specific Alkaline Phosphatase(baseline to 5 days)
Study Sites (1)
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