Growth DisorderNCT02580032

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)

An observational study of Growth Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 28 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 4 to 13 years
Conditions the study is for: Growth Disorder, Growth Hormone Deficiency in Children
What is being tested?: No treatment given
How many people: 252 participants
Where: 28 sitesin 2 countries
Study dates: 5 Oct 2015to 14 May 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 13 years
All sexes
No healthy volunteers
Child

Study population: The 2 populations (child and parent/guardian) will each be divided into a Treatment Naïve group and a Maintenance group.

Who may be able to join

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)

Show all 45Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

28 sites in 2 countries.

Country

City, postcode or hospital

28 sites in 2 countries

United States24 sites

Novo Nordisk Investigational Site
Albany, New York, 12208-3412
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342-1551
Novo Nordisk Investigational Site
Boston, Massachusetts, 02114
Novo Nordisk Investigational Site
Buffalo, New York, 14203
Novo Nordisk Investigational Site
Centennial, Colorado, 80112
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
Columbus, Ohio, 43235
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75235
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Lebanon, New Hampshire, 03756-1000
Novo Nordisk Investigational Site
Louisville, Kentucky, 40202
Novo Nordisk Investigational Site
Margate, Florida, 33063
Novo Nordisk Investigational Site
Miami, Florida, 33155
Novo Nordisk Investigational Site
Mineola, New York, 11501
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
Phoenix, Arizona, 85054
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15218
Novo Nordisk Investigational Site
Saint Paul, Minnesota, 55102
Novo Nordisk Investigational Site
Spring Valley, New York, 10977
Novo Nordisk Investigational Site
St Louis, Missouri, 63017
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Wheaton, Illinois, 60187
Novo Nordisk Investigational Site
Wilmington, Delaware, 19803

Other trials in United States

United Kingdom4 sites

Novo Nordisk Investigational Site
Birmingham, B4 6NH
Novo Nordisk Investigational Site
Liverpool, L12 2AP
Novo Nordisk Investigational Site
London, WC1N 3JH
Novo Nordisk Investigational Site
Manchester, M13 9WL

Other trials in United Kingdom

About this study

Conditions: Growth Disorder, Growth Hormone Deficiency in Children
Being tested: No treatment given
Medical subject headings: Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No treatment givenOther
No treatment given.

Study groups in NCT02580032
Study group	Role	What they receive
Child Treatment Naïve group (Group A)		Pre-pubertal boy or girl, ages of 9 to 13 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of equal or below 7.0 ng/ml. Receives: Other: No treatment given
Child Maintenance group (Group B)		Pre-pubertal boy or girl, ages of 9 to 13 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of equal or below 10.0 ng/ml who have been taking prescription treatment for GHD for 6 months or more. Receives: Other: No treatment given
Parent Treatment Naïve group (Group C)		Parents/guardians, who live with a pre-pubertal boy or girl, age 4 to 9 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of below or equal to 7.0 ng/ml. Receives: Other: No treatment given
Parent Maintenance group (Group D)		Parents/guardians, who live with a pre-pubertal boy or girl, age 4 to 9 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of below or equal to 10.0 ng/ml who have been taking prescription treatment for GHD for 6 months or more. Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in CGI (Clinician Global Impression Scale)
Measured: After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment

Secondary outcomes (1)

Changes in PGI (Patient Global Impression Scale)
Measured: After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 201514 May 2018

First posted20 Oct 2015 (estimated)
Study start5 Oct 2015
Primary completion14 May 2018
Study completion14 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Growth DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02580032
Sponsor's protocol ID: NN8640-4231
Other IDs: U1111-1168-7911
Status last verified: Sep 2020
First submitted: 16 Oct 2015
Last updated: 25 Sep 2020
Results posted: No
Data monitoring committee: No

Publications

Brod M, Rasmussen MH, Alolga S, Beck JF, Bushnell DM, Lee KW, Maniatis A. Psychometric Validation of the Growth Hormone Deficiency-Child Treatment Burden Measure (GHD-CTB) and the Growth Hormone Deficiency-Parent Treatment Burden Measure (GHD-PTB). Pharmacoecon Open. 2023 Jan;7(1):121-138. doi: 10.1007/s41669-022-00373-z. Epub 2022 Oct 18.
PubMed 36255609
Brod M, Hojby Rasmussen M, Vad K, Alolga S, Bushnell DM, Bedoin J, Maniatis A. Psychometric Validation of the Growth Hormone Deficiency-Child Impact Measure (GHD-CIM). Pharmacoecon Open. 2021 Sep;5(3):505-518. doi: 10.1007/s41669-020-00252-5. Epub 2021 Jan 12.
PubMed 33433896

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02580032
Acronym / sponsor ID: NN8640-4231
Conditions: Growth Disorder, Growth Hormone Deficiency in Children
Study type: Observational
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 5 Oct 2015 (actual)
Primary completion: 14 May 2018 (actual)
Study completion: 14 May 2018 (actual)
First posted: 20 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Child Treatment Naïve group (Group A)	–	Other: No treatment givenPre-pubertal boy or girl, ages of 9 to 13 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of equal or below 7.0 ng/ml.
Child Maintenance group (Group B)	–	Other: No treatment givenPre-pubertal boy or girl, ages of 9 to 13 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of equal or below 10.0 ng/ml who have been taking prescription treatment for GHD for 6 months or more.
Parent Treatment Naïve group (Group C)	–	Other: No treatment givenParents/guardians, who live with a pre-pubertal boy or girl, age 4 to 9 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of below or equal to 7.0 ng/ml.
Parent Maintenance group (Group D)	–	Other: No treatment givenParents/guardians, who live with a pre-pubertal boy or girl, age 4 to 9 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of below or equal to 10.0 ng/ml who have been taking prescription treatment for GHD for 6 months or more.

Who may qualify

Ages: 4 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: The 2 populations (child and parent/guardian) will each be divided into a Treatment Naïve group and a Maintenance group.

Key inclusion criteria (45 listed)

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)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No treatment givenNo treatment given.	Other	Child Maintenance group (Group B), Child Treatment Naïve group (Group A), Parent Maintenance group (Group D), Parent Treatment Naïve group (Group C)

Primary outcome

Changes in CGI (Clinician Global Impression Scale)
Time frame: After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment

1 secondary outcome

Changes in PGI (Patient Global Impression Scale)
Time frame: After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Derived from this study: PubMed 36255609Brod M, Rasmussen MH, Alolga S, Beck JF, Bushnell DM, Lee KW, Maniatis A. Psychometric Validation of the Growth Hormone Deficiency-Child Treatment Burden Measure (GHD-CTB) and the Growth Hormone Deficiency-Parent Treatment Burden Measure (GHD-PTB). Pharmacoecon Open. 2023 Jan;7(1):121-138. doi: 10.1007/s41669-022-00373-z. Epub 2022 Oct 18.
Derived from this study: PubMed 33433896Brod M, Hojby Rasmussen M, Vad K, Alolga S, Bushnell DM, Bedoin J, Maniatis A. Psychometric Validation of the Growth Hormone Deficiency-Child Impact Measure (GHD-CIM). Pharmacoecon Open. 2021 Sep;5(3):505-518. doi: 10.1007/s41669-020-00252-5. Epub 2021 Jan 12.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

28 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Growth Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 28 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in CGI (Clinician Global Impression Scale) (time frame: After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02580032, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.