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

Phase 3

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency

• Registration Number: NCT00184678
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in bone mineralisation	After 2 years treatment

Secondary Outcome Measures

Name	Time	Method
Other markers of bone mineral content.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom