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

NCT00720122 | Completed Phase 2 Results DMC

• 2 other identifiers: MassGHCDER
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Disorder of Bone Density and Structure, Unspecified

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Study Arms (1)

Anorexia Nervosa Females

EXPERIMENTAL

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

Interventions

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

Twice daily

Also known as: Tercica

Anorexia Nervosa Females

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Meet criteria for anorexia nervosa (AN) as described in the Diagnostic and Statistical Manual of Mental Disorders

You may not qualify if:

• 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-

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: Madhusmita Misra, M.D., Associate Professor in Pediatrics, Assistant Pediatrician
• Organization: Massachusetts General Hospital

mmisra@partners.org

617-724-5602

Study Officials

• Madhusmita Misra, MD

  MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssociate Professor of Pediatrics

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 18, 2021
• Results First Posted: February 29, 2012

Record last verified: 2021-10

Locations

US (1)