Growth Hormone Treatment of Women With Turner Syndrome

Britta E. Hjerrild

Status: Completed

Conditions: Turner Syndrome

Treatments: Drug: Growth Hormone; Drug: Placebo; Other: Healthy controls

Study type: Interventional

Funder types: Other

Identifiers

NCT00420654

2005-BH-GH

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 3 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: Growth Hormone

A2

Placebo Comparator group

Treatment:

Drug: Placebo

A3

Other group

Treatment:

Other: Healthy controls