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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184678

Enrollment

161

Registered

2005-09-16

Start date

2002-02-28

Completion date

2006-07-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Growth Hormone Deficiency, Growth Hormone Disorder

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.

Interventions

DRUGsomatropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame
Changes in bone mineralisation	After 2 years treatment

Secondary

Measure	Time frame
Other markers of bone mineral content.	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026