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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184678
First Posted: September 16, 2005
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
September 13, 2005
September 16, 2005
January 13, 2017
February 2002
July 2006   (Final data collection date for primary outcome measure)
Changes in bone mineralisation [ Time Frame: After 2 years treatment ]
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.
Same as current
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
Drug: somatropin
Not Provided
  • Zacharin M, Szarras-Czapnik M, Racz K, Keller A, Tauber M, Conway G. Growth hormone (GH) treatment improves bone mineral density during transition of GH-deficient patients from adolescence to adulthood. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki
  • Zacharin M, Keller A, Chanson P, Conway G on behalf of the 1369 GHD to GHDA. Efficacy of two years' growth hormone (GH) treatment on bone mineral density in young adults with childhood-onset GH deficiency. The Endocrine Society Annual Meeting (ENDO) 2007; Country: Canada City: Toronto
  • Conway G, Scarras-Czapnik M, Racz K, Keller A, Chanson P, Kappelgaard A M, Zacharin M, Hyldstrup L. Direct X-ray radiogrammetry versus dual-energy X-ray absorptiometry: assessment of bone density in young adult with childhood-onset growth hormone deficiency treated with growth hormone. The Endocrine Society Annual Meeting (ENDO) 2008; Country: USA City: San Francisco

*   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
Sexes Eligible for Study: All
18 Years to 25 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   France,   Germany,   Hungary,   Norway,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom
 
 
NCT00184678
GHLIQUID-1369
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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