NCT00625001

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 1994

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1994

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1996

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 28, 2008

Status Verified

February 1, 2008

Enrollment Period

1.9 years

First QC Date

February 19, 2008

Last Update Submit

February 19, 2008

Conditions

Turner Syndrome

Keywords

Turner Syndromebone mineral densityestrogen replacement therapydual energy x-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

Women with Turner syndrome

2

Healthy control women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with Turner syndrome

You may qualify if:

  • Turner syndrome verified by karyotyping

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Turner Syndrome

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

November 1, 1994

Primary Completion

October 1, 1996

Study Completion

June 1, 2010

Last Updated

February 28, 2008

Record last verified: 2008-02