Trials / Completed
CompletedNCT00420654
Growth Hormone Treatment of Women With Turner Syndrome
Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Britta E. Hjerrild · Academic / Other
- Sex
- Female
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.
Detailed description
This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET). Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Growth Hormone | 1.25 mg, 6 months |
| DRUG | Placebo | Equivalent to 1.25 mg, 6 months |
| OTHER | Healthy controls | Healthy controls |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2007-01-11
- Last updated
- 2011-11-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00420654. Inclusion in this directory is not an endorsement.