A randomised dose comparison study of recombinant human growth hormone effects on metabolism markers in children with growth hormone (GH) deficiency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44127724

Enrollment

Registered

2003-09-12

Start date

2002-06-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Nutritional, Metabolic, Endocrine: Growth hormone deficiency Nutritional, Metabolic, Endocrine Growth hormone deficiency

Interventions

Patients will attend a screening visit (combined with the usual visit to teach child and parent how to inject GH and familiarise them with the pen) for collection of informed consent (patients and par

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Recruitment and number of subjects: Maximum recruitment of five pre-pubertal newly diagnosed GH-deficient patients in whom a clinical decision is made that they would benefit from treatment with GH and who wish to take part in study (subject to inclusion/exclusion criteria in accordance with protocol).

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Measurements: Blood samples will be sent to central laboratories for analysis. Parameters to be analysed are as follows: Glucose, HbA1C, insulin, total cholesterol, triglycerides, high density lipoproteins (HDL) and low density lipoprotein (LDL) cholesterol; bone-specific isoenzymes: calcaemia, phosphoraemia, alkaline phosphatase; markers of bone formation and resorption: osteocalcin, N-telopeptide, C-telopeptide, total deoxypyridinoline and type 3 procollagen; insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGF-BP3), ALS, IGF-BP1; dehydroepiandrosterone sulphate (DHEA-S), testosterone, antimullerian hormone (AMH) (boys only); free thyroxine (FT4), leptin; parathyroid hormone (PTH) and vitamin D (25OH-D). Evaluation of primary efficacy endpoint: This is an investigational study with a principal objective of identifying primary endpoints from a battery of biological markers for later use in a second study. Consequently this study does not have any pre-specified primary outcome measures.	—

Measure

Time frame

Measurements: Blood samples will be sent to central laboratories for analysis. Parameters to be analysed are as follows: Glucose, HbA1C, insulin, total cholesterol, triglycerides, high density lipoproteins (HDL) and low density lipoprotein (LDL) cholesterol; bone-specific isoenzymes: calcaemia, phosphoraemia, alkaline phosphatase; markers of bone formation and resorption: osteocalcin, N-telopeptide, C-telopeptide, total deoxypyridinoline and type 3 procollagen; insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGF-BP3), ALS, IGF-BP1; dehydroepiandrosterone sulphate (DHEA-S), testosterone, antimullerian hormone (AMH) (boys only); free thyroxine (FT4), leptin; parathyroid hormone (PTH) and vitamin D (25OH-D). Evaluation of primary efficacy endpoint: This is an investigational study with a principal objective of identifying primary endpoints from a battery of biological markers for later use in a second study. Consequently this study does not have any pre-specified primary outcome measures.

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Secondary

Measure	Time frame
Evaluation of secondary efficacy endpoints: For each of the biological markers, an appropriate parametric or non-parametric statistical analysis will be employed to investigate differences between dose groups at the 3-month assessment while adjusting for appropriate co-variates.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026