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

NCT ID: NCT00184678

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Growth Hormone Disorder Adult Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Parkville, Victoria, Australia

Site Status

Novo Nordisk Investigational Site

Auckland, , Australia

Site Status

Novo Nordisk Investigational Site

Hamilton, , Australia

Site Status

Novo Nordisk Investigational Site

Subiaco, , Australia

Site Status

Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Brussels, , Belgium

Site Status

Novo Nordisk Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

Novo Nordisk Investigational Site

Marseille Cédex 05, , France

Site Status

Novo Nordisk Investigational Site

Toulouse, , France

Site Status

Novo Nordisk Investigational Site

Essen, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt, , Germany

Site Status

Novo Nordisk Investigational Site

Heidelberg, , Germany

Site Status

Novo Nordisk Investigational Site

Krefeld, , Germany

Site Status

Novo Nordisk Investigational Site

Leipzig, , Germany

Site Status

Novo Nordisk Investigational Site

Magdeburg, , Germany

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Szeged, , Hungary

Site Status

Novo Nordisk Investigational Site

Oslo, , Norway

Site Status

Novo Nordisk Investigational Site

Gdansk, , Poland

Site Status

Novo Nordisk Investigational Site

Krakow, , Poland

Site Status

Novo Nordisk Investigational Site

Szczecin, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Wroclaw, , Poland

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Bern, , Switzerland

Site Status

Novo Nordisk Investigational Site

Lausanne, , Switzerland

Site Status

Novo Nordisk Investigational Site

Glasgow, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Countries

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Australia Austria Belgium France Germany Hungary Norway Poland Spain Sweden Switzerland United Kingdom

References

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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

Reference Type 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

Reference Type 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

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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GHLIQUID-1369

Identifier Type: -

Identifier Source: org_study_id

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