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

This study has been completed.

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Amy DiVasta, Children's Hospital Boston

ClinicalTrials.gov Identifier:

NCT01100567

First received: April 7, 2010

Last updated: August 5, 2015

Last verified: August 2015

History of Changes

Purpose

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.

Condition	Intervention
Anorexia Nervosa	Device: Low-magnitude mechanical stimulation platform


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA

Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:

pQCT measures of bone geometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bone turnover markers [ Time Frame: q 3 months ] [ Designated as safety issue: No ]


Enrollment:	51
Study Start Date:	April 2009
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo platform Randomized to stand on placebo platform for 10 minutes/day	Device: Low-magnitude mechanical stimulation platform Low-magnitude mechanical stimulation platform
Active Comparator: Low-magnitude mechanical stimulation Randomized to stand on LMMS platform 10 minutes/daily	Device: Low-magnitude mechanical stimulation platform Low-magnitude mechanical stimulation platform

Eligibility


Ages Eligible for Study:	11 Years to 25 Years (Child, Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100567

Locations


United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Boston Children’s Hospital

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Amy D DiVasta, MD, MMSc	Boston Children’s Hospital

More Information


Responsible Party:	Amy DiVasta, Principal Investigator, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01100567 History of Changes
Other Study ID Numbers:	08-10-0461
Study First Received:	April 7, 2010
Last Updated:	August 5, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Children’s Hospital:


skeletal health bone turnover bone geometry malnutrition

Additional relevant MeSH terms:


Anorexia Anorexia Nervosa Signs and Symptoms, Digestive	Signs and Symptoms Feeding and Eating Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016

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