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Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

NCT ID: NCT03033121

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-01-01

Brief Summary

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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.

Detailed Description

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Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, No 16) or three injections per week (group B, No 16) GH therapy for 12 months.

Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI) were evaluated in the two groups of patients.

Conditions

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Growth Hormone Treatment

Keywords

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growth hormone children metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

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.

Group Type ACTIVE_COMPARATOR

Growth Hormone

Intervention Type DRUG

group B

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.

Group Type ACTIVE_COMPARATOR

Growth Hormone

Intervention Type DRUG

Interventions

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Growth Hormone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Growth hormone deficiency clinically and biochemically demonstrated

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Carla Giordano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endocrinology - University of Palermo

Palermo, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 28634491 (View on PubMed)

Other Identifiers

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3-wk-GH

Identifier Type: -

Identifier Source: org_study_id