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

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184678

Purpose

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.

Condition	Intervention	Phase
Growth Hormone Deficiency (GHD)	Drug: somatropin	Phase III

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Minerals

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Growth Hormone on Bone Mineralisation in Young Adults With Child-Hood-Onset Growth Hormone Deficiency After 2 Years.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Other markers of bone mineral content.

Estimated Enrollment:	180
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184678

Locations

Poland

Warsaw, Poland

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anders Dejgaard, MD

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-1369
Study First Received:	September 13, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00184678
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Novo Nordisk:

GHDA

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Central Nervous System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009