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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities

ClinicalTrials.gov processed this record on November 25, 2014