Efficacy and safety of a 4 year combination therapy of growth hormone and gonadotropin- releasing hormone agonist in children with a short predicted height.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003247-70-BE

Enrollment

Registered

2007-10-24

Start date

2007-10-29

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

predicted short stature MedDRA version: 9.1 Level: LLT Classification code 10066333 Term: Idiopathic short stature

Interventions

Trade Name: Zomacton Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o Adult height prediction below –2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)o Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boyso Bone age >10 years but 11 but =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: o Adopted children ( different genetic background, lack of data on birth parameters and parents)o Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)o Chronic use of glucocorticoids o Previous growth promoting therapy such as GH, sex steroids, oxandrolone, o Known GH deficiencyo Chronic infectious diseaseo Active rheumatic diseaseo Previously diagnosed or currently suspected malignancyo Sex steroid therapyo Diabetes mellituso Renal insufficiency (serum creatinine > 1.5 mg/dl)o Hepatic disease ( liver test > 4 fold upper limit of normality)o Current congestive heart failureo Inability to follow the study protocolo Treatment with a non registered drug during the last 30 days before the moment of inclusion

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary ojectives are:oTo test the hypothesis that the prediction of adult height in the controls is not different from the adult height attained.oTo test the hypothesis that adult height, attained after the 4 year combination therapy, is different from the predicted adult height at the start of the study.oTo monitor the safety of the combination therapy.oTo calculate the effect of several parameters ( birth weight, birth length, gestational age, maternal height, paternal height, age at onset of therapy, bone age at the onset of therapy) on adult height both in the treated as in the control group.oTo test the hypothesis that bone mineral density at final height is not different between treated and untreated patientsoTo test the hypothesis that the dimensions of the ovaries and the uterus, or testes at final height are not different between treated and untreated patients.;Primary end point(s): Final height;Main Objective: The primary objective of this study is to test the hypothesis that adult height is taller in children with idiopathic short stature at the beginning of puberty after a 4 year combination therapy with GH (Zomacton) and a GnRH agonist (Triptoreline) than in matched controls that received no treatment.	—

Measure

Time frame

Secondary Objective: Secondary ojectives are:oTo test the hypothesis that the prediction of adult height in the controls is not different from the adult height attained.oTo test the hypothesis that adult height, attained after the 4 year combination therapy, is different from the predicted adult height at the start of the study.oTo monitor the safety of the combination therapy.oTo calculate the effect of several parameters ( birth weight, birth length, gestational age, maternal height, paternal height, age at onset of therapy, bone age at the onset of therapy) on adult height both in the treated as in the control group.oTo test the hypothesis that bone mineral density at final height is not different between treated and untreated patientsoTo test the hypothesis that the dimensions of the ovaries and the uterus, or testes at final height are not different between treated and untreated patients.;Primary end point(s): Final height;Main Objective: The primary objective of this study is to test the hypothesis that adult height is taller in children with idiopathic short stature at the beginning of puberty after a 4 year combination therapy with GH (Zomacton) and a GnRH agonist (Triptoreline) than in matched controls that received no treatment.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 11, 2026