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Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00283595
First received: January 27, 2006
Last updated: September 15, 2012
Last verified: September 2012

January 27, 2006
September 15, 2012
January 2006
February 2009   (final data collection date for primary outcome measure)
Bone Metabolism [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
Bone Metabolism
Complete list of historical versions of study NCT00283595 on ClinicalTrials.gov Archive Site
IGF-1 Level [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Change in IGF-1 level between baseline and 12 weeks
Not Provided
Not Provided
Not Provided
 
Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
Effect of Supraphysiological rhGH on Bone Metabolism in Patients With 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.

  • 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Anorexia Nervosa
  • Osteopenia
  • Osteoporosis
  • Eating Disorders
  • Drug: Recombinant Human Growth Hormone
    Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
    Other Name: Nutropin AQ
  • 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
  • Active Comparator: 1
    Treatment with rHGH
    Intervention: Drug: Recombinant Human Growth Hormone
  • Placebo Comparator: 2
    Treatment with Placebo
    Intervention: Drug: Placebo for Recombinant Human Growth Hormone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
14 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283595
2005-P-001443/3; MGH
Yes
Anne Klibanski, MD, Massachusetts General Hospital
Massachusetts General Hospital
Genentech, Inc.
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP