- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283595
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusettes General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Treatment with rHGH
|
Dosage increased in steps for first four weeks.
Self injection qd x 12 weeks
Other Names:
|
PLACEBO_COMPARATOR: 2
Treatment with Placebo
|
Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IGF-1 Level
Time Frame: Baseline, 12 Weeks
|
Change in IGF-1 level between baseline and 12 weeks
|
Baseline, 12 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-P-001443/3; MGH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
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Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
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Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Atypical Anorexia NervosaUnited States
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CinnagenCompleted
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Hamilton Health Sciences CorporationCompleted
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