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

January 12, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auckland, Australia, 1
        • Novo Nordisk Investigational Site
      • Hamilton, Australia, 2303
        • Novo Nordisk Investigational Site
      • Subiaco, Australia, 6008
        • Novo Nordisk Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Novo Nordisk Investigational Site
  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • Novo Nordisk Investigational Site
  • France
      • Le Kremlin-bicetre, France, 94275
        • Novo Nordisk Investigational Site
      • MARSEILLE Cédex 05, France, 13385
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31059
        • Novo Nordisk Investigational Site
  • Germany
      • Essen, Germany, 45122
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
      • Heidelberg, Germany, 69115
        • Novo Nordisk Investigational Site
      • Krefeld, Germany, 47805
        • Novo Nordisk Investigational Site
      • Leipzig, Germany, 04317
        • Novo Nordisk Investigational Site
      • Magdeburg, Germany, 39112
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1135
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1088
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, 6720
        • Novo Nordisk Investigational Site
  • Norway
      • Oslo, Norway, 0027
        • Novo Nordisk Investigational Site
  • Poland
      • Cracow, Poland, 30-663
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-952
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 71-455
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 04-736
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-376
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Novo Nordisk Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novo Nordisk Investigational Site
      • Lausanne, Switzerland, 1011
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Novo Nordisk Investigational Site
      • London, United Kingdom, W1N 8AA
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in bone mineralisation
Time Frame: After 2 years treatment
After 2 years treatment

Secondary Outcome Measures

Outcome Measure
Other markers of bone mineral content.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHLIQUID-1369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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