Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)

Completed

Conditions studied: Growth Disorder, Growth Hormone Deficiency in Children

In brief

This study is conducted in Europe and the United States of America (USA). The aim of the study is to validate two measures for growth hormone deficiency in children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).

Key facts

Study ID: NCT02580032
Run by: Novo Nordisk A/S
People needed: 252
Starts: 2015-10-05
Expected to finish: 2018-05-14
Last updated by the study team: 2020-09-25

Who can join

Age: 4 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Informed consent obtained
Child population - treatment näive:
Confirmed diagnosis of Growth Hormone Deficiency (GHD) prior to enrolment as determined by a Growth Hormone (GH) stimulation test, defined as a peak GH level of 7.0 ng/ml or less. The GH stimulation test will be according to local clinical standards
Pre pubertal children age 9 to less than 13 years at enrolment
No prior exposure to GH therapy (GH-treatment naïve)
Annualized height velocity (HV) below the 25th percentile for Chronological Age (CA) (HV less than -0.7 SD scores) and sex according to the standards of Prader et al (1989)
Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts
Child population - maintenance patients:
Confirmed diagnosis of GHD prior to enrolment as determined by a GH stimulation test, defined as a peak GH level of 10.0 ng/ml or less. The GH stimulation test will be according to local clinical standards
Pre pubertal children age 9 to less than 13 years at enrolment
Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts
Parent/Guardian population - treatment näive:
Parent/Guardian of child with a confirmed diagnosis of GHD prior to enrolment as determined by a GH stimulation test, defined as a peak GH level of 7.0 ng/ml or less. The GH stimulation test will be according to local clinical standards
Parent/Guardian of pre pubertal child age 4 to less than 9 years at enrolment
Parent/Guardian of child with no prior exposure to GH therapy (GH-treatment naïve)
Parent/Guardian of child with annualized height velocity (HV) below the 25th percentile for CA (HV less than -0.7 SD scores) and sex according to the standards of Prader et al (1989)
Parent/Guardian of child with Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts
Parent/Guardian living in the same residence as the child at least 50% of the time
Parent/Guardian population - maintenance patients:
Parent/Guardian of child with confirmed diagnosis of GHD prior to enrolment as determined by a GH stimulation test, defined as a peak GH level of 10.0 ng/ml or less. The GH stimulation test will be according to local clinical standards
Parent/Guardian of pre pubertal child age 4 to less than 9 years at enrolment
Parent/Guardian of child with Body Mass Index (BMI) percentile greater than 5th and below 95th percentile according to Centers for Disease Control and Prevention (CDC) BMI-for-age growth charts
Parent/Guardian living in the same residence as the child at least 50% of the time Exclusion Criteria:
Child population - treatment näive and maintenance patients:
Any clinically significant abnormality likely to affect growth or the ability to evaluate growth:

Where it is running

Novo Nordisk Investigational Site — Phoenix, Arizona, United States
Novo Nordisk Investigational Site — Centennial, Colorado, United States
Novo Nordisk Investigational Site — Wilmington, Delaware, United States
Novo Nordisk Investigational Site — Margate, Florida, United States
Novo Nordisk Investigational Site — Miami, Florida, United States
Novo Nordisk Investigational Site — Tallahassee, Florida, United States
Novo Nordisk Investigational Site — Atlanta, Georgia, United States
Novo Nordisk Investigational Site — Wheaton, Illinois, United States
Novo Nordisk Investigational Site — Iowa City, Iowa, United States
Novo Nordisk Investigational Site — Louisville, Kentucky, United States
Novo Nordisk Investigational Site — Boston, Massachusetts, United States
Novo Nordisk Investigational Site — Saint Paul, Minnesota, United States
Novo Nordisk Investigational Site — St Louis, Missouri, United States
Novo Nordisk Investigational Site — Lebanon, New Hampshire, United States
Novo Nordisk Investigational Site — Albany, New York, United States
Novo Nordisk Investigational Site — Buffalo, New York, United States
Novo Nordisk Investigational Site — Mineola, New York, United States
Novo Nordisk Investigational Site — New York, New York, United States
Novo Nordisk Investigational Site — Spring Valley, New York, United States
Novo Nordisk Investigational Site — Cleveland, Ohio, United States
Novo Nordisk Investigational Site — Columbus, Ohio, United States
Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
Novo Nordisk Investigational Site — Dallas, Texas, United States
Novo Nordisk Investigational Site — Dallas, Texas, United States
Novo Nordisk Investigational Site — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.