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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Turner syndrome

MedlinePlus related topics: Minerals Turner Syndrome X-Rays

U.S. FDA Resources

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

No publications provided

Responsible Party:	University of Aarhus ( MD, Dr. Med. Sci Claus Gravholt )
Study ID Numbers:	1994/2424
Study First Received:	February 19, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00625001 History of Changes
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:

Estrogens
Gonadal Disorders
Genital Dwarfism
Chromosome Disorders
Endocrine System Diseases
Ovarian Dwarfism
Hormones
Sex Differentiation Disorders

Monosomy X
Turner Syndrome
Urogenital Abnormalities
Genetic Diseases, Inborn
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Chromosome Disorders
Endocrine System Diseases
Sex Differentiation Disorders
Turner Syndrome
Pathologic Processes

Urogenital Abnormalities
Genetic Diseases, Inborn
Syndrome
Sex Chromosome Disorders
Congenital Abnormalities
Gonadal Dysgenesis

ClinicalTrials.gov processed this record on September 04, 2009