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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:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00184678
First received: September 13, 2005
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  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 Disorder
Adult Growth Hormone Deficiency
 Drug: somatropin
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Somatropin
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: June 28, 2012
Health Authority: Sweden: Medical Products Agency

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 May 22, 2013