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Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa

NCT ID: NCT00720122

Last Updated: 2021-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Disorder of Bone Density and Structure, Unspecified

Keywords

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Bone density Bone turnover markers rhIGF-1 Bone structure Anorexia nervosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anorexia Nervosa Females

Group Type EXPERIMENTAL

Recombinant human insulin like growth factor-1 (rhIGF-1)

Intervention Type DRUG

Twice daily

Interventions

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Recombinant human insulin like growth factor-1 (rhIGF-1)

Twice daily

Intervention Type DRUG

Other Intervention Names

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Tercica

Eligibility Criteria

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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-
Minimum Eligible Age

12 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Madhusmita Misra

Asssociate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhusmita Misra, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CDER

Identifier Type: -

Identifier Source: secondary_id

MassGH

Identifier Type: -

Identifier Source: org_study_id