Effects of Anorexia Nervosa on Peak Bone Mass

What Was Tested

This registered phase 3 trial tested IGF-1 LR3 and Mecasermin (rhIGF-1).

Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of bone accrual, raising concerns regarding acquisition of peak bone mass, an important determinant of future bone health and fracture risk.

Important factors contributing to low bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1).

It had two arms (groups): Rh IGF-1 + Transdermal estradiol (experimental) and Placebo + Transdermal estradiol (placebo comparator).

RhIGF-1 with transdermal 17-beta estradiol.

Placebo and transdermal 17-beta estradiol.

The registry classes the interventions as drug.

More on the Plan

Furthermore, the magnitude and mechanisms by which IGF-1 deficiency and hypogonadism influence bone microarchitecture are not defined.

The growing incidence of eating disorders in adolescent girls and their long-term effects on skeletal health provide strong rationale for studies that will provide a better understanding of these issues and the evaluation of rational therapeutic approaches.

The studies described in this proposal utilize both cross-sectional and RCT approaches to achieve this goal.

Who Took Part

75 actual participants took part.

It was open to women only aged from 14 years up to 22 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age: 14-22 years old. Bone age (BA): ≥14 years. Should meet DSM IV criteria for AN. Healthy adolescent girls 14-22 years. BA of ≥14 years.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: medications known to affect bone metabolism, including gonadal steroids, within three months; evidence of suicidality, psychosis, or substance abuse; abnormal tsh.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this IGF-1 LR3 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind IGF-1 LR3 study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2011-02 with completion listed for 2019-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Bone Density Over a 12-month Period (time frame: 12 months).

It also tracked 1 secondary outcome, for example Change in Trabecular Number at the Ultradistal Radius Over a 12-month Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of IGF-1 LR3 and Mecasermin (rhIGF-1) in 75 people.

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 and the Mecasermin (rhIGF-1) compound page, all human trials.