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

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test IGF-1 LR3.

It had 1 arm (groups): Insulin like growth factor- 1 (IGF-1) (experimental).

The registry classes the interventions as drug.

More on the Plan

Adolescents 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 I (IGF-I), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels GH.

It is possible that deficiency of IGF-I, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in AN.

The goal of this proposal was to investigate the acute effects of rhIGF-I on bone metabolism in adolescent girls with AN.

Who Took Part

The registry lists 16 actual participants took part.

It was open to women only aged from 12 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adolescent girls with anorexia nervosa 12-18 years old.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: pregnancy or nursing; any illness (other than anorexia nervosa) known to affect bone and mineral metabolism such as diabetes, alcoholism, untreated hypo- or hyperthyroidism, or hyperparathyroidism.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when IGF-1 LR3 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-03 with completion listed for 2008-05.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa (time frame: Baseline and 7-10 days).

It also tracked 1 secondary outcome, for example Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of IGF-1 LR3 in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the IGF-1 LR3 compound page, all human trials.