Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa
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ClinicalTrials.gov Identifier: NCT01100567 |
Recruitment Status :
Completed
First Posted : April 9, 2010
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anorexia Nervosa | Device: Low-magnitude mechanical stimulation platform | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo platform
Randomized to stand on placebo platform for 10 minutes/day
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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
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Device: Low-magnitude mechanical stimulation platform
Low-magnitude mechanical stimulation platform |
- Change From Baseline in C-telopeptides [ Time Frame: Baseline to 5 days ]
- Change From Baseline in Bone Specific Alkaline Phosphatase [ Time Frame: baseline to 5 days ]

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Ages Eligible for Study: | 11 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 11-25 years
- Diagnosis of anorexia nervosa based on DSM-IV criteria
- Female gender
- English-speaking
Exclusion Criteria:
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• Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100567
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Amy D DiVasta, MD, MMSc | Boston Children's Hospital |
Responsible Party: | Amy DiVasta, Principal Investigator, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT01100567 |
Other Study ID Numbers: |
08-10-0461 |
First Posted: | April 9, 2010 Key Record Dates |
Results First Posted: | May 17, 2017 |
Last Update Posted: | May 17, 2017 |
Last Verified: | April 2017 |
skeletal health bone turnover bone geometry malnutrition |
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Feeding and Eating Disorders Mental Disorders |