CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Recombinant human insulin like growth factor-1 (rhIGF-1)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00720122
NCT00720122Phase 2Completed

Effects of Recombinant Human Insulin Like Growth Factor-1 (rhIGF-1) on Bone Metabolism in Adolescent Girls With Anorexia Nervosa

Massachusetts General Hospital·interventional·Posted Jul 22, 2008·Updated Nov 18, 2021

In Brief

A Phase 2 clinical trial evaluating Recombinant human insulin like growth factor-1 (rhIGF-1) for Disorder of Bone Density and Structure, Unspecified. Completed, enrolled 28 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartJul 1, 2008
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.9 years ago

Interventions

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

Twice daily