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

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Device: Low-magnitude mechanical stimulation platform

• Registration Number: NCT01100567
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-11-29
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-magnitude mechanical stimulation	Low-magnitude mechanical stimulation platform	Randomized to stand on LMMS platform 10 minutes/daily
Placebo platform	Low-magnitude mechanical stimulation platform	Randomized to stand on placebo platform for 10 minutes/day

Primary Outcome Measures

Name	Time	Method
Change From Baseline in C-telopeptides	Baseline to 5 days

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Bone Specific Alkaline Phosphatase	baseline to 5 days

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States