NCT01100567CompletedNot Applicable
EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
Boston Children's Hospital1 site in 1 country101 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Change From Baseline in C-telopeptides
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 11 Years to 25 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
Placebo platform
Placebo Comparator
Randomized to stand on placebo platform for 10 minutes/day
Intervention: Low-magnitude mechanical stimulation platform (Device)
Low-magnitude mechanical stimulation
Active Comparator
Randomized to stand on LMMS platform 10 minutes/daily
Intervention: Low-magnitude mechanical stimulation platform (Device)
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)
Investigators
Amy DiVasta
Principal Investigator
Boston Children's Hospital
Study Sites (1)
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