Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa (814)
Primary Purpose
Disorder of Bone Density and Structure, Unspecified
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant human insulin like growth factor-1 (rhIGF-1)
Sponsored by
About this trial
This is an interventional treatment trial for Disorder of Bone Density and Structure, Unspecified focused on measuring Bone density, Bone turnover markers, rhIGF-1, Bone structure, Anorexia nervosa
Eligibility Criteria
Inclusion Criteria:
- Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders
Exclusion Criteria:
- Pregnant or nursing
- Hematocrit < 30%, K < 3 mmol/L
- Any illness (other than AN) known to affect bone and mineral metabolism such as diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism
- History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study because our data in adult women with AN do not indicate deleterious effects of estrogen in patients receiving rhIGF-
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anorexia Nervosa Females
Arm Description
Outcomes
Primary Outcome Measures
Change in Spine Bone Density (g/cm^2)
Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT00720122
First Posted
July 18, 2008
Last Updated
October 22, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00720122
Brief Title
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Acronym
814
Official Title
Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of insulin-like growth factor 1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents and young adults with anorexia nervosa have not been studied. The goal of this proposal is to investigate the effects of recombinant human insulin-like growth factor 1 on bone density and bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a 6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients, being insulin-like growth factor 1 deficient, will respond to exogenously administered recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure, or maintain bone density (in contrast to the decrease in bone density expected in adolescent girls and women with anorexia nervosa who are not treated).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Bone Density and Structure, Unspecified
Keywords
Bone density, Bone turnover markers, rhIGF-1, Bone structure, Anorexia nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anorexia Nervosa Females
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Recombinant human insulin like growth factor-1 (rhIGF-1)
Other Intervention Name(s)
Tercica
Intervention Description
Twice daily
Primary Outcome Measure Information:
Title
Change in Spine Bone Density (g/cm^2)
Description
Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders
Exclusion Criteria:
Pregnant or nursing
Hematocrit < 30%, K < 3 mmol/L
Any illness (other than AN) known to affect bone and mineral metabolism such as diabetes, untreated hypo- or hyperthyroidism, or hyperparathyroidism
History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who are on estrogen will still be eligible to participate in the study because our data in adult women with AN do not indicate deleterious effects of estrogen in patients receiving rhIGF-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhusmita Misra, MD
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa
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