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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00184678
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
• Scientific title: Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency
• Date of first enrolment: February 2002
• Target sample size: 161
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00184678
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, France, Germany, Hungary, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Disorder

Adult Growth Hormone Deficiency

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Changes in bone mineralisation [Time Frame: After 2 years treatment]

Secondary Outcome(s)

Other markers of bone mineral content.

Secondary ID(s)

GHLIQUID-1369

Source(s) of Monetary Support

Please refer to primary and secondary sponsors