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Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT00283595
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : October 16, 2012
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anorexia Nervosa Osteopenia Osteoporosis Eating Disorders Drug: Recombinant Human Growth Hormone Drug: Placebo for Recombinant Human Growth Hormone Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
Study Start Date : January 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Treatment with rHGH
 Drug: Recombinant Human Growth Hormone
Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
Other Name: Nutropin AQ
Placebo Comparator: 2
Treatment with Placebo
 Drug: Placebo for Recombinant Human Growth Hormone
Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
Other Name: Placebo for Nutropin AQ


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. IGF-1 Level [ Time Frame: Baseline, 12 Weeks ]
    Change in IGF-1 level between baseline and 12 weeks


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283595


Locations
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United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Investigators
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Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
More Information
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Responsible Party: Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00283595    
Other Study ID Numbers: 2005-P-001443/3; MGH
First Posted: January 30, 2006    Key Record Dates
Results First Posted: October 16, 2012
Last Update Posted: September 2, 2020
Last Verified: August 2020
Keywords provided by Karen Klahr Miller, MD, Massachusetts General Hospital:
Anorexia Nervosa
Eating disorder
Bone
 Growth hormone
Osteopenia
Osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Mental Disorders
Signs and Symptoms, Digestive
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs