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NCT00625001 Clinical Trial

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

Turner Syndrome Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00625001
Other study ID # 1994/2424
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 19, 2008
Last updated February 19, 2008
Start date November 1994
Est. completion date June 2010

Study information
Verified date February 2008
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 54
Est. completion date June 2010
Est. primary completion date October 1996
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Evey 5 years No
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