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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-magnitude mechanical stimulation platform
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring skeletal health, bone turnover, bone geometry, malnutrition

Eligibility Criteria

11 Years - 25 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo platform

Low-magnitude mechanical stimulation

Arm Description

Randomized to stand on placebo platform for 10 minutes/day

Randomized to stand on LMMS platform 10 minutes/daily

Outcomes

Primary Outcome Measures

Change From Baseline in C-telopeptides

Secondary Outcome Measures

Change From Baseline in Bone Specific Alkaline Phosphatase

Full Information

First Posted
April 7, 2010
Last Updated
April 7, 2017
Sponsor
Boston Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01100567
Brief Title
Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa
Official Title
EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
skeletal health, bone turnover, bone geometry, malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo platform
Arm Type
Placebo Comparator
Arm Description
Randomized to stand on placebo platform for 10 minutes/day
Arm Title
Low-magnitude mechanical stimulation
Arm Type
Active Comparator
Arm Description
Randomized to stand on LMMS platform 10 minutes/daily
Intervention Type
Device
Intervention Name(s)
Low-magnitude mechanical stimulation platform
Intervention Description
Low-magnitude mechanical stimulation platform
Primary Outcome Measure Information:
Title
Change From Baseline in C-telopeptides
Time Frame
Baseline to 5 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Bone Specific Alkaline Phosphatase
Time Frame
baseline to 5 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy D DiVasta, MD, MMSc
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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