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

Adult Growth Hormone Deficiency Clinical Trial

Official title:

Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184678
• Other study ID #: GHLIQUID-1369
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 12, 2017
• Start date: February 2002
• Est. completion date: July 2006

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

Drug:
• somatropin

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Auckland
Australia	Novo Nordisk Investigational Site	Hamilton
Australia	Novo Nordisk Investigational Site	Parkville	Victoria
Australia	Novo Nordisk Investigational Site	Subiaco
Austria	Novo Nordisk Investigational Site	Graz
Belgium	Novo Nordisk Investigational Site	Bruxelles
France	Novo Nordisk Investigational Site	Le Kremlin-bicetre
France	Novo Nordisk Investigational Site	MARSEILLE Cédex 05
France	Novo Nordisk Investigational Site	TOULOUSE cedex
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Frankfurt
Germany	Novo Nordisk Investigational Site	Heidelberg
Germany	Novo Nordisk Investigational Site	Krefeld
Germany	Novo Nordisk Investigational Site	Leipzig
Germany	Novo Nordisk Investigational Site	Magdeburg
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Szeged
Norway	Novo Nordisk Investigational Site	Oslo
Poland	Novo Nordisk Investigational Site	Cracow
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Szczecin
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Wroclaw
Spain	Novo Nordisk Investigational Site	Barcelona
Sweden	Novo Nordisk Investigational Site	Göteborg
Switzerland	Novo Nordisk Investigational Site	Bern
Switzerland	Novo Nordisk Investigational Site	Lausanne
United Kingdom	Novo Nordisk Investigational Site	Glasgow
United Kingdom	Novo Nordisk Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

References & Publications (3)

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 deficien

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;

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone mineralisation		After 2 years treatment
Secondary	Other markers of bone mineral content.

External Links

•   Clinical Trials at Novo Nordisk