Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

IGF-1

Insulin-like Growth Factor 1, Somatomedin C

Quick Stats
Studies 92
Trials 100
Withdrawn PHASE1 INTERVENTIONAL NCT04021017

PRE-GAiN Bone Health Pilot Study

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study will assess the affects of an estradiol hemihydrate transdermal system on bone health in 24 adolescent females aged 12-19 years old with anorexia nervosa. Participants in this study will be randomized 1:1 into 2 groups. One group will receive treatment with a transdermal estrogen patch and the other group will not.

Detailed Description

Currently, no therapy exists to improve bone health in females with anorexia nervosa (AN) other than improving body mass. Transdermal estrogen is being investigated as to whether it has benefit to bone health parameters. While numerous studies have sought to orally replace estrogen in adolescents and women with AN, the replacement therapy suppresses IGF-1, and as a result oral estrogen studies have demonstrated no bone health benefit in AN. However, transdermal physiologic estrogen, due to no first-pass metabolism in the liver, is not IGF-1 suppressive. IGF-1 is known to be hormone that directly affects bone formation and is considered to be osteoanabolic (helps increase bone mass).

Interventions

Name: Estradiol Hemihydrate Transdermal System
Type: DRUG
Description: Participants who have had their first period or have a bone age greater than or equal to 14 years will receive PrClimara® 25 (estradiol hemihydrate transdermal system - 25 mcg/day) as a weekly patch, for 24 months. Participants who have not yet had their first period and have a bone age below 14 years will receive an increasing dose of estrogen. These participants will be initiated on graduated dose of transdermal 17-β estradiol patches: 3.1 mcg/day (1/8 patch) for first six-months, 6.2 mcg/day (1/4 patch) for second six-months, 12.5 mcg/day (1/2 patch) for third six-months and 25 mcg/day (full patch) for final six-months.

Primary Outcomes

Measure: Cortical Wall Thickness
TimeFrame: Change from Baseline to Month 24
Description: Cortical wall thickness as measured by high resolution peripheral quantitative computed tomography (HR-pQCT).

Trial Information

NCT ID

NCT04021017

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

University of Saskatchewan

Last Updated

December 15, 2025