Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Tercica
• Treatments: Insulin; Insulin, Globin Zinc; Mecasermin; Mitogens

Criteria

Inclusion Criteria:

• Adolescent girls with anorexia nervosa 12-18 years old

Exclusion Criteria:

• Pregnancy or nursing

• Hematocrit < 30%, K < 3 mmol/L

• Any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism

• History of use of any medicine, such as corticosteroids, known to affect bone density. Subjects who were on estrogen were still eligible to participate in the study.