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Growth Hormone Treatment of Women With Turner Syndrome

NCT ID: NCT00420654

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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

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Turner Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Growth Hormone

Intervention Type DRUG

1.25 mg, 6 months

A2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Equivalent to 1.25 mg, 6 months

A3

Group Type OTHER

Healthy controls

Intervention Type OTHER

Healthy controls

Interventions

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Growth Hormone

1.25 mg, 6 months

Intervention Type DRUG

Placebo

Equivalent to 1.25 mg, 6 months

Intervention Type DRUG

Healthy controls

Healthy controls

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Britta E. Hjerrild

OTHER

Sponsor Role lead

Responsible Party

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Britta E. Hjerrild

MD PhD Clinical assistent

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens S. Christiansen, prof. dr.med

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, DK, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2005-BH-GH

Identifier Type: -

Identifier Source: org_study_id