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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bone Loss in Patients With Anorexia Nervosa

NCT01907464

Patients With Anorexia Nervosa

UNKNOWN NA

Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years

NCT02891356

Anorexia Nervosa Osteoporosis

COMPLETED

Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.

NCT02526927

Anorexia Nervosa

COMPLETED NA

Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

NCT00556036

Anorexia Nervosa Hypothalamic Amenorrhea Obesity

COMPLETED

PRE-GAiN Bone Health Pilot Study

NCT04021017

Anorexia Nervosa

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Nervosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo platform

Randomized to stand on placebo platform for 10 minutes/day

Group Type PLACEBO_COMPARATOR

Low-magnitude mechanical stimulation platform

Intervention Type DEVICE

Low-magnitude mechanical stimulation platform

Low-magnitude mechanical stimulation

Randomized to stand on LMMS platform 10 minutes/daily

Group Type ACTIVE_COMPARATOR

Low-magnitude mechanical stimulation platform

Intervention Type DEVICE

Low-magnitude mechanical stimulation platform

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-magnitude mechanical stimulation platform

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No