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Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Genentech
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
History of Changes
  Purpose

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 Intervention Phase
Anorexia Nervosa
Osteopenia
Osteoporosis
Eating Disorders
 Drug: Recombinant Human Growth Hormone
Drug: Placebo for Recombinant Human Growth Hormone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • IGF-1 Level [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    Change in IGF-1 level between baseline and 12 weeks


Enrollment: 21
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283595

Locations
United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genentech
Investigators
Principal Investigator: Anne Klibanski, MD Massachusetts General Hospital
  More Information

Additional Information:
Group Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Anne Klibanski, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00283595     History of Changes
Other Study ID Numbers: 2005-P-001443/3; MGH
Study First Received: January 27, 2006
Results First Received: August 16, 2012
Last Updated: September 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Anorexia Nervosa
Eating disorder
Bone
 Growth hormone
Osteopenia
Osteoporosis

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
Bone Diseases, Metabolic
Osteoporosis
Signs and Symptoms, Digestive
Signs and Symptoms
 Mental Disorders
Bone Diseases
Musculoskeletal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013