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

This study has been completed.

First Received on September 13, 2005. Last Updated on May 29, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Growth Hormone on Bone Mineralisation in Young Adults With Child-Hood-Onset Growth Hormone Deficiency After 2 Years.

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Minerals

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Changes in bone mineralisation [ Time Frame: After 2 years treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other markers of bone mineral content. [ Designated as safety issue: No ]

Enrollment:	161
Study Start Date:	February 2002
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00184678 History of Changes
Other Study ID Numbers:	GHLIQUID-1369
Study First Received:	September 13, 2005
Last Updated:	May 29, 2009
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Novo Nordisk:

GHDA

Additional relevant MeSH terms:

Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases

Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012