Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Phase 2

Completed

• Conditions: Osteoporosis; Anorexia Nervosa; Osteopenia; Eating Disorders
• Interventions: Drug: Placebo for Recombinant Human Growth Hormone; Drug: Recombinant Human Growth Hormone

• Registration Number: NCT00283595
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

* Twelve week study

* Eight visits, six of which can be conducted at your home physician's office

* Two bone density scans

* Hormonal and nutritional evaluations

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-30
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-08-16
• Results First Submitted QC: 2012-09-15
• Results First Posted: 2012-10-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo for Recombinant Human Growth Hormone	Treatment with Placebo
1	Recombinant Human Growth Hormone	Treatment with rHGH

Primary Outcome Measures

Name	Time	Method
Bone Metabolism	Baseline, 12 weeks	Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
IGF-1 Level	Baseline, 12 Weeks	Change in IGF-1 level between baseline and 12 weeks

Trial Locations

Locations (1)

Massachusettes General Hospital; 🇺🇸 Boston, Massachusetts, United States