A Multicenter, Observational Study to Characterize Growth in Children With Idiopathic Short Stature

Status: Recruiting
Location: See all (19) locations...
Study Type: Observational
SUMMARY

Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: f
View:

• Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.

• A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm).

• Participants who have either never received hGH, or who are currently receiving hGH treatment.

• Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.

• Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.

Locations
United States
California
Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)
RECRUITING
Los Angeles
Center Of Excellence in Diabetes and Endocrinology
RECRUITING
Sacramento
University of California San Francisco (UCSF)
RECRUITING
San Francisco
Washington, D.c.
Children's National Health System
RECRUITING
Washington D.c.
Florida
Nemours Children's Clinic
RECRUITING
Jacksonville
Nicklaus Children's Hospital
RECRUITING
Miami
Nemours Children's Health System - Corporate Headquarters
RECRUITING
Pensacola
Georgia
Centricity Research
RECRUITING
Columbus
Idaho
St. Luke's Children's Endocrinology
RECRUITING
Boise
Rocky Mountain Clinical Research - Idaho Falls
RECRUITING
Idaho Falls
Kentucky
University of Louisville School Of Medicine - Norton Children's Hospital
RECRUITING
Louisville
Minnesota
University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic
RECRUITING
Minneapolis
New York
UBMD Pediatrics
RECRUITING
Buffalo
ACGC Research, NYU Ambulatory Care Garden City
RECRUITING
Garden City
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates
RECRUITING
New York
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
RECRUITING
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center Burnet Campus
RECRUITING
Cincinnati
Texas
Cook Children's Endocrinology
RECRUITING
Fort Worth
West Virginia
Charleston Area Medical Center (CAMC) Health System
RECRUITING
Charleston
Contact Information
Primary
Trial Specialist
Medinfo@bmrn.com
18009834587
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2040-12-31
Participants
Target number of participants: 300
Sponsors
Leads: BioMarin Pharmaceutical

This content was sourced from clinicaltrials.gov

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