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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00625001
First received: February 19, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome

Resource links provided by NLM:

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

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

Additional relevant MeSH terms:
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
 Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013