Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Osteoporosis; Osteopenia; Eating Disorders; Anorexia Nervosa

Treatments: Drug: Placebo for Recombinant Human Growth Hormone; Drug: Recombinant Human Growth Hormone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00283595

2005-P-001443/3 MGH;

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Treatment with rHGH

Treatment:

Drug: Recombinant Human Growth Hormone

2

Placebo Comparator group

Description:

Treatment with Placebo

Treatment:

Drug: Placebo for Recombinant Human Growth Hormone