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

Boston Children's Hospital

Status

Completed

Conditions

Anorexia Nervosa

Treatments

Device: Low-magnitude mechanical stimulation platform

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01100567

08-10-0461

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

Female

Ages

11 to 25 years old

Volunteers

No Healthy Volunteers

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