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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
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Changes in bone mineralisation [ Time Frame: After 2 years treatment ]

Secondary Outcome Measures:
  • Other markers of bone mineral content.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184678


  Show 30 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184678     History of Changes
Other Study ID Numbers: GHLIQUID-1369
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
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