Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184678

GHLIQUID-1369

Details and patient eligibility

About

This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

Enrollment: 161 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Child-hood onset growth hormone deficiency
• Subjects received growth hormone replacement therapy during pre-puberty and puberty

Exclusion criteria

• GH treatment during the month preceding randomisation
• Treatment within the previous 6 months with medication that may affect bone mineral density
• Diseases which may affect bone metabolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)