Growth Hormone Treatment of Women With Turner Syndrome

Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420654

Enrollment

Registered

2007-01-11

Start date

2007-08-31

Completion date

2011-09-30

Last updated

2011-11-08

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

Conditions

Turner Syndrome

Keywords

Turner syndrome, growth hormone treatment, positron emission tomography, heart

Brief 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

Interventions

DRUGGrowth Hormone

1.25 mg, 6 months

DRUGPlacebo

Equivalent to 1.25 mg, 6 months

OTHERHealthy controls

Healthy controls

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Turner syndrome * Age 20-40

Exclusion criteria

* Symptomatic heart disease * Anti hypertensive treatment * Untreated thyroid disease * Adipositas (BMI \> 35) * Treatment with glucocorticoids * Pregnancy

Design outcomes

Primary

Measure	Time frame
Body composition: fat mass and lean body mass	6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography	6 months

Secondary

Measure	Time frame
Heart function evaluated by echocardiography (conventional and tissue doppler)	6 months + 18 months
Lipid profile	6 months + 18 months
24 hour ambulatory blood pressure	6 months + 18 months

Countries

Denmark

Outcome results

None listed

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