NCT03033121

Brief Summary

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

January 18, 2017

Last Update Submit

October 25, 2017

Conditions

Growth Hormone Treatment

Keywords

growth hormonechildrenmetabolism

Outcome Measures

Primary Outcomes (12)

  • height

    height (standard deviation)

    12 months

  • weight

    weight (kilograms)

    12 months

  • body mass index

    body mass index (kilograms/m2)

    12 months

  • Insulin growth factor-I

    insulin growth factor (IGF)-I (ug/L)

    12 months

  • glucose

    glucose (mmol/l) during oral glucose tolerance test

    12 months

  • insulin

    insulin (uU/ml) during oral glucose tolerance test

    12 months

  • glycated hemoglobin

    glycated hemoglobin (%)

    12 months

  • ISI Matsuda

    Insulin Sensitivity Index

    12 months

  • Oral disposition index

    Oral Disposition Index (DIo)

    12 months

  • Homa IR

    The homeostatic model assessment of insulin resistance

    12 months

  • LDL cholesterol

    Low Density Lipoprotein cholesterol (mmol/l)

    12 months

  • Triglycerides

    triglycerides (mmol/l)

    12 months

Study Arms (2)

group A

ACTIVE COMPARATOR

Sixteen growth hormone (GH) deficiency children were assigned to receive daily growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.

Drug: Growth Hormone

group B

ACTIVE COMPARATOR

Sixteen growth hormone (GH) deficiency children were assigned to receive three time weekly growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.

Drug: Growth Hormone

Interventions

Growth HormoneDRUG
group Agroup B

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Growth hormone deficiency clinically and biochemically demonstrated

You may not qualify if:

  • Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology - University of Palermo

Palermo, 90127, Italy

Location

Related Publications (1)

  • Ciresi A, Ciccio F, Radellini S, Guarnotta V, Calcaterra AM, Giordano C. More Favorable Metabolic Impact of Three-Times-Weekly versus Daily Growth Hormone Treatment in Naive GH-Deficient Children. Int J Endocrinol. 2017;2017:8469680. doi: 10.1155/2017/8469680. Epub 2017 May 28.

    PMID: 28634491DERIVED

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 26, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)