Human evidence record · Somatropin (recombinant human growth hormone)

Recombinant GH replacement in adult growth-hormone deficiency

GH replacement improved several deficiency-related outcomes including body composition in the diagnosed GHD population.

Quick read

Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with confirmed growth-hormone deficiency

How many?

n=166

What happened?

GH replacement improved several deficiency-related outcomes including body composition in the diagnosed GHD population.

What stops us overclaiming?

Evidence applies to diagnosed GH deficiency and regulated somatropin, not anti-ageing/bodybuilding use in otherwise healthy adults.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary →

Key result

GH replacement improved several deficiency-related outcomes including body composition in the diagnosed GHD population.

Study details

Study designRandomized double-blind placebo-controlled multicenter trial

PopulationAdults with confirmed growth-hormone deficiency

Sample size166

RouteSubcutaneous

Regimen / exposure0.0125 mg/kg/day initially, titrated up to 0.025 mg/kg/day as tolerated

Duration12 months

ComparatorPlacebo

Primary endpoint / questionBody composition, lipids, exercise capacity and quality of life

Safety resultClass adverse effects are dose-related and require clinical monitoring.

Key limitationsEvidence applies to diagnosed GH deficiency and regulated somatropin, not anti-ageing/bodybuilding use in otherwise healthy adults.

Registry / identifierPMID 15126520

Open Somatropin (recombinant human growth hormone) page →Open primary source →