Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Osteoporosis Clinical Trial

Official title:

Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283595
• Other study ID #: 2005-P-001443/3; MGH
• Status: Completed
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: February 2009

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bone Diseases, Metabolic
• Eating Disorders
• Feeding and Eating Disorders
• Osteopenia
• Osteoporosis

Intervention

Drug:
• Recombinant Human Growth Hormone
Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
• Placebo for Recombinant Human Growth Hormone
Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks

Locations

Country	Name	City	State
United States	Massachusettes General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Metabolism	Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks	Baseline, 12 weeks
Secondary	IGF-1 Level	Change in IGF-1 level between baseline and 12 weeks	Baseline, 12 Weeks