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

Primary Purpose

Growth Hormone Disorder, Adult Growth Hormone Deficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Disorder

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Changes in bone mineralisation

Secondary Outcome Measures

Other markers of bone mineral content.

Full Information

First Posted
September 13, 2005
Last Updated
January 12, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00184678
Brief Title
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
Official Title
Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Adult Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Changes in bone mineralisation
Time Frame
After 2 years treatment
Secondary Outcome Measure Information:
Title
Other markers of bone mineral content.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Auckland
ZIP/Postal Code
1
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
ZIP/Postal Code
2303
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MARSEILLE Cédex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
04317
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Cracow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
04-736
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Wroclaw
ZIP/Postal Code
50-376
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
W1N 8AA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Citation
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
Results Reference
result
Citation
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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