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)



Status:Completed
Conditions:Endocrine, Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:4 - 13
Updated:9/15/2018
Start Date:October 5, 2015
End Date:May 14, 2018

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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).


Inclusion Criteria:

- 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:

- a) Chromosomal abnormalities and medical "syndromes", e.g. but not limited to Turner's
syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors

- b) Congenital abnormalities (causing skeletal abnormalities), e.g. but not limited to
Russell-Silver Syndrome, skeletal dysplasia's

- c) Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants - Children born small for gestational age (SGA - birth weight and/or birth
length less than -2 SD for gestational age)

- Children diagnosed with diabetes mellitus or fasting blood glucose greater than or
equal to 126 mg/dl (7.0 mmol/L), or HbA1c greater than or equal to 6.5% at enrolment

- Current inflammatory diseases (e.g. but not limited to arthritis, inflammatory bowel
diseases) requiring systemic corticosteroid treatment or glucocorticoids treatment for
longer than 2 weeks within the last 3 months prior to enrolment

- Children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of
greater than 400 µg/day of inhaled budesonide or equivalents for longer than 1 month
the year prior to enrolment

- Concomitant administration of other treatments that may have an effect on growth, e.g.
but not limited to anabolic steroids and methylphenidate for attention deficit
hyperactivity disorder (ADHD). Hormone replacement therapies (thyroxin,
hydrocortisone, desmopressin) are allowed for inclusion

- Any disorder which, in the opinion of the investigator, might jeopardise subject's
safety or compliance with the protocol

- The subject and/or the parent/Legally Acceptable Representative (LAR) are likely to be
non-compliant in respect to trial conduct, as judged by the investigator

- Parent/Guardian population - treatment näive and maintenance patients:

- Parent/Guardian of child with any clinically significant abnormality likely to affect
growth or the ability to evaluate growth:

- a) Chromosomal abnormalities and medical "syndromes", e.g. but not limited to Turner's
syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors

- b) Congenital abnormalities (causing skeletal abnormalities), e.g. but not limited to
Russell-Silver Syndrome, skeletal dysplasia's

- c) Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants - Parent/Guardian of child born small for gestational age (SGA - birth weight
and/or birth length less than -2 SD for gestational age)

- Parent/Guardian of child diagnosed with diabetes mellitus or fasting blood glucose
greater than or equal to 126 mg/dl (7.0 mmol/L), or HbA1c greater than or equal to
6.5% at enrolment

- Parent/Guardian of child with current inflammatory diseases (e.g. but not limited to
arthritis, inflammatory bowel diseases) requiring systemic corticosteroid treatment or
glucocorticoids treatment for longer than 2 weeks within the last 3 months prior to
enrolment

- Parent/Guardian of children requiring glucocorticoid therapy (e.g. asthma) who are
taking a dose of greater than 400 µg/day of inhaled budesonide or equivalents for
longer than 1 month the year prior to enrolment

- Parent/Guardian of child with concomitant administration of other treatments that may
have an effect on growth, e.g. but not limited to anabolic steroids and
methylphenidate for attention deficit hyperactivity disorder (ADHD). Hormone
replacement therapies (thyroxin, hydrocortisone, desmopressin) are allowed for
inclusion

- Parent/Guardian of child with any disorder which, in the opinion of the investigator,
might jeopardise subject's safety or compliance with the protocol

- The subject and/or the parent/LAR are likely to be non-compliant in respect to trial
conduct, as judged by the investigator
We found this trial at
24
sites
Dallas, Texas 75231
1541
mi
from 02139
Dallas, TX
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Albany, New York 12208
138
mi
from 02139
Albany, NY
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Atlanta, Georgia 30318
934
mi
from 02139
Atlanta, GA
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?
mi
from 02139
Birmingham,
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Boston, Massachusetts 02115
1
mi
from 02139
Boston, MA
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Buffalo, New York 14222
396
mi
from 02139
Buffalo, NY
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Centennial, Colorado 80112
1760
mi
from 02139
Centennial, CO
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Cleveland, Ohio 44106
547
mi
from 02139
Cleveland, OH
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Columbus, Ohio 43205
640
mi
from 02139
Columbus, OH
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Iowa City, Iowa 52242
1048
mi
from 02139
Iowa City, IA
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Lebanon, New Hampshire 03756
105
mi
from 02139
Lebanon, NH
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Louisville, Kentucky 40213
821
mi
from 02139
Louisville, KY
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Margate, Florida 33063
1227
mi
from 02139
Margate, FL
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Miami, Florida 33136
1256
mi
from 02139
Miami, FL
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Mineola, New York 11501
172
mi
from 02139
Mineola, NY
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New York, New York 10029
182
mi
from 02139
New York, NY
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Phoenix, Arizona 85053
2292
mi
from 02139
Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
479
mi
from 02139
Pittsburgh, PA
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Saint Louis, Missouri 63110
1033
mi
from 02139
Saint Louis, MO
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Saint Paul, Minnesota 55102
1110
mi
from 02139
Saint Paul, MN
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Spring Valley, New York 10977
163
mi
from 02139
Spring Valley, NY
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Tallahassee, Florida 32308
1095
mi
from 02139
Tallahassee, FL
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Wheaton, Illinois 60187
870
mi
from 02139
Wheaton, IL
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Wilmington, Delaware 19803
293
mi
from 02139
Wilmington, DE
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