Phase 2
Completed N=16
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Source: ClinicalTrials.gov NCT00516386 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Aug 2011
Primary outcomePrimary: Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa — 542.9 ng/ml — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa |
542.9 | <0.05 sig |
| SECONDARY Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa |
39.3 | <0.05 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00516386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.