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N/A N=101 Randomized Triple-blind Treatment

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

Anorexia Nervosa

Bottom Line

View on ClinicalTrials.gov: NCT01100567 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline in C-telopeptides — 0.083; -0.027 ng/mL/day

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Low-magnitude mechanical stimulation platform (Device)
Age
Pediatric, Adult · 11+ yrs
Sex
Female
Sponsor
Boston Children's Hospital
Primary completion
May 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in C-telopeptides		 0.083; -0.027 —
SECONDARY
Change From Baseline in Bone Specific Alkaline Phosphatase		 -0.07; -0.36 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01100567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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