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

Anorexia Nervosa Clinical Trial

Official title:

EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100567
• Other study ID #: 08-10-0461
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: August 5, 2015
• Start date: April 2009
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 25 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Device:
• Low-magnitude mechanical stimulation platform
Low-magnitude mechanical stimulation platform

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pQCT measures of bone geometry		6 months	No
Secondary	Bone turnover markers		q 3 months	No