Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children (GH 3 wk dose)

University of Palermo

Status and phase: Completed; Phase 3

Conditions: Growth Hormone Treatment

Treatments: Drug: Growth Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT03033121

3-wk-GH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

group A

Active Comparator group

Description:

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.

Treatment:

Drug: Growth Hormone

group B

Active Comparator group

Description:

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.

Treatment:

Drug: Growth Hormone