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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184678
First received: September 13, 2005
Last updated: June 28, 2012
Last verified: June 2012

September 13, 2005
June 28, 2012
February 2002
July 2006   (final data collection date for primary outcome measure)
Changes in bone mineralisation [ Time Frame: After 2 years treatment ] [ Designated as safety issue: No ]
Changes in bone mineralisation after 2 years treatment.
Complete list of historical versions of study NCT00184678 on ClinicalTrials.gov Archive Site
Other markers of bone mineral content. [ Designated as safety issue: No ]
Other markers of bone mineral content.
Not Provided
Not Provided
 
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
Drug: somatropin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00184678
GHLIQUID-1369
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Anders Dejgaard, MD Novo Nordisk A/S
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP