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OpenTrials
Completed

NCT Number: NCT00283595

Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Bone Diseases Bone Diseases, Metabolic Eating Disorders Feeding and Eating Disorders Mental Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massachusettes General Hospital

Boston, Massachusetts, 02114, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant human growth hormone

Drug

Dosage increased in steps for first four weeks. Self injection qd x 12 weeks

Other names: Nutropin AQ

Placebo for Recombinant Human Growth Hormone

Drug

Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks

Other names: Placebo for Nutropin AQ

Primary outcomes

  1. Bone Metabolism

    Time frame: 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 outcomes

  1. IGF-1 Level

    Time frame: Baseline, 12 Weeks

    Change in IGF-1 level between baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 30, 2006
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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