NCT01100567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

6.1 years

First QC Date

April 7, 2010

Results QC Date

November 29, 2016

Last Update Submit

April 7, 2017

Conditions

Anorexia Nervosa

Keywords

skeletal healthbone turnoverbone geometrymalnutrition

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in C-telopeptides

    Baseline to 5 days

Secondary Outcomes (1)

  • Change From Baseline in Bone Specific Alkaline Phosphatase

    baseline to 5 days

Study Arms (2)

Placebo platform

PLACEBO COMPARATOR

Randomized to stand on placebo platform for 10 minutes/day

Device: Low-magnitude mechanical stimulation platform

Low-magnitude mechanical stimulation

ACTIVE COMPARATOR

Randomized to stand on LMMS platform 10 minutes/daily

Device: Low-magnitude mechanical stimulation platform

Interventions

Low-magnitude mechanical stimulation platformDEVICE

Low-magnitude mechanical stimulation platform

Low-magnitude mechanical stimulationPlacebo platform

Eligibility Criteria

Age11 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 11-25 years
  • Diagnosis of anorexia nervosa based on DSM-IV criteria
  • Female gender
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • DiVasta AD, Stamoulis C, Rubin CT, Gallagher JS, Kiel DP, Snyder BD, Gordon CM. Low-Magnitude Mechanical Signals to Preserve Skeletal Health in Female Adolescents With Anorexia Nervosa: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2441779. doi: 10.1001/jamanetworkopen.2024.41779.

    PMID: 39480424DERIVED

  • Lin JA, Stamoulis C, DiVasta AD. Associations between nutritional intake, stress and hunger biomarkers, and anxiety and depression during the treatment of anorexia nervosa in adolescents and young adults. Eat Behav. 2023 Dec;51:101822. doi: 10.1016/j.eatbeh.2023.101822. Epub 2023 Oct 26.

    PMID: 38504970DERIVED

MeSH Terms

Conditions

Anorexia NervosaMalnutrition

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Amy DiVasta, PI
Organization
Boston Children's Hospital
amy.divasta@childrens.harvard.edu
6173553792

Study Officials

  • Amy D DiVasta, MD, MMSc

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Study Start

April 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 17, 2017

Results First Posted

May 17, 2017

Record last verified: 2017-04

Locations

US(1)