Phase 2 N=21 Randomized Single-blind Treatment

Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Anorexia Nervosa · Osteopenia · Osteoporosis · Eating Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00283595 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Bone Metabolism — 34.3; 10.4 ng/ml

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Recombinant Human Growth Hormone (Drug); Placebo for Recombinant Human Growth Hormone (Drug)
Age: Pediatric, Adult · 14+ yrs
Sex: Female
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Bone Metabolism	34.3; 10.4	—
SECONDARY IGF-1 Level	6.5; 10	—

Summary

Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength. We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.

Eligibility Criteria

Inclusion Criteria

women between 14 to 45 years with anorexia nervosa

Exclusion Criteria

pregnancy
previous history of malignancy.
oral contraceptive pills or other hormones within last 8 - 12 weeks
medications known to affect bone within last 12 weeks
fracture within last 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00283595). 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.