Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-Hood Onset Growth Hormone Deficiency.
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency (GHD)
Intervention: somatropin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Anders Dejgaard, MD, Study Director, Affiliation: Novo Nordisk A/S
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.
Clinical Details
Official title: Effect of Growth Hormone on Bone Mineralisation in Young Adults With Child-Hood-Onset Growth Hormone Deficiency After 2 Years.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Changes in bone mineralisation
Secondary outcome: Other markers of bone mineral content.
Eligibility
Minimum age: 18 Years.
Maximum age: 25 Years.
Gender(s): Both.
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
Locations and Contacts
Warsaw, Poland
Additional Information
Clinical Trials at Novo Nordisk
Starting date: February 2002
Last updated: September 10, 2007
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