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Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome

This study is ongoing, but not recruiting participants.

Sponsored by: University of Aarhus
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00625001
  Purpose

Turner Syndrome (TS) is associated with osteopenia and osteoporosis. Reduced bone mineral density (BMD) and increased risk of fractures are present in many younger and middle-aged women with TS. The objective is therefore to describe longitudinal changes in BMD in TS.

The study is an observational follow-up study. Examinations at baseline, after 5 and 10 years.

Bone mineral density is measured by dual energy x-ray absorptiometry (DEXA) and bone turnover by bone markers.

Main Outcome Measures: Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm.


Condition
Turner Syndrome

Genetics Home Reference related topics:   Turner syndrome   

MedlinePlus related topics:   Minerals    Turner Syndrome    X-Rays   

ChemIDplus related topics:   X-Rays   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Bone Mineral Density in columna lumbalis, collum femoris and distal ulnae Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm. [ Time Frame: Evey 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Blood samples


Enrollment:   54
Study Start Date:   November 1994
Estimated Study Completion Date:   June 2010
Primary Completion Date:   October 1996 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
Women with Turner syndrome
2
Healthy control women

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Women with Turner syndrome


Criteria

Inclusion Criteria:

  • Turner syndrome verified by karyotyping

Exclusion Criteria:

  • untreated hypothyroidism or hyperthyroidism
  • present or past malignant diseases
  • clinical liver disease
  • treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)
  Contacts and Locations

No Contacts or Locations Provided
  More Information

Responsible Party:   University of Aarhus ( MD, Dr. Med. Sci Claus Gravholt )
Study ID Numbers:   1994/2424
First Received:   February 19, 2008
Last Updated:   February 19, 2008
ClinicalTrials.gov Identifier:   NCT00625001
Health Authority:   Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Turner Syndrome  
bone mineral density  
estrogen replacement therapy  
dual energy x-ray absorptiometry  

Study placed in the following topic categories:
Chromosomal abnormalities
Genital dwarfism
Gonadal Disorders
Chromosome Disorders
Endocrine System Diseases
Monosomy X
Turner Syndrome
Gonadal dysgenesis
Urogenital Abnormalities
Genetic Diseases, Inborn
Turner syndrome
Ovarian dwarfism
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Sex Chromosome Disorders
Sex Differentiation Disorders

ClinicalTrials.gov processed this record on September 05, 2008




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