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

NCT00184678 | Completed Phase 3

• 1 other identifier: GHLIQUID-1369
• Study Type: interventional
• Target: 161
• Locations: 11 countries
• Sites: 26

Brief 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.

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Changes in bone mineralisation

  After 2 years treatment

Secondary Outcomes (1)

• Other markers of bone mineral content.

Interventions

somatropin DRUG

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Child-hood onset growth hormone deficiency
• Subjects received growth hormone replacement therapy during pre-puberty and puberty

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (30)

Novo Nordisk Investigational Site

Parkville, Victoria, 3052, Australia

Location

Novo Nordisk Investigational Site

Auckland, 1, Australia

Location

Novo Nordisk Investigational Site

Hamilton, 2303, Australia

Location

Novo Nordisk Investigational Site

Subiaco, 6008, Australia

Location

Novo Nordisk Investigational Site

Graz, 8036, Austria

Location

Novo Nordisk Investigational Site

Brussels, 1200, Belgium

Location

Novo Nordisk Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

Novo Nordisk Investigational Site

Marseille Cédex 05, 13385, France

Location

Novo Nordisk Investigational Site

Toulouse, 31059, France

Location

Novo Nordisk Investigational Site

Essen, 45122, Germany

Location

Novo Nordisk Investigational Site

Frankfurt, 60590, Germany

Location

Novo Nordisk Investigational Site

Heidelberg, 69115, Germany

Location

Novo Nordisk Investigational Site

Krefeld, 47805, Germany

Location

Novo Nordisk Investigational Site

Leipzig, 04317, Germany

Location

Novo Nordisk Investigational Site

Magdeburg, 39112, Germany

Location

Novo Nordisk Investigational Site

Budapest, 1088, Hungary

Location

Novo Nordisk Investigational Site

Budapest, 1135, Hungary

Location

Novo Nordisk Investigational Site

Szeged, 6720, Hungary

Location

Novo Nordisk Investigational Site

Oslo, 0027, Norway

Location

Novo Nordisk Investigational Site

Gdansk, 80-952, Poland

Location

Novo Nordisk Investigational Site

Krakow, 30-663, Poland

Location

Novo Nordisk Investigational Site

Szczecin, 71-455, Poland

Location

Novo Nordisk Investigational Site

Warsaw, 04-736, Poland

Location

Novo Nordisk Investigational Site

Wroclaw, 50-376, Poland

Location

Novo Nordisk Investigational Site

Barcelona, 08035, Spain

Location

Novo Nordisk Investigational Site

Gothenburg, 413 45, Sweden

Location

Novo Nordisk Investigational Site

Bern, 3010, Switzerland

Location

Novo Nordisk Investigational Site

Lausanne, 1011, Switzerland

Location

Novo Nordisk Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Novo Nordisk Investigational Site

London, W1N 8AA, United Kingdom

Location

Related Publications (3)

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

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; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

PL (5); SE (1); GB (2); BE (1); FR (3); CH (2); AU (1); NO (1); DE (6); ES (1); HU (3)