Turner SyndromeNCT00625001
Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome
An observational study of Turner Syndrome, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Nov 1994to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with Turner syndrome
Who may be able to join
- Turner syndrome verified by karyotyping
Who cannot join
- untreated hypothyroidism or hyperthyroidism
- present or past malignant diseases
- clinical liver disease
- treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)
About this study
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.
- Conditions
- Turner Syndrome
- Keywords
- Turner Syndrome, bone mineral density, estrogen replacement therapy, dual energy x-ray absorptiometry
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with Turner syndrome | |
| 2 | Healthy control women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evey 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startNov 1994
- Primary completionOct 1996
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625001
- Sponsor's protocol ID
- 1994/2424
- Status last verified
- Feb 2008
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome
- ClinicalTrials.gov ID
- NCT00625001
- Acronym / sponsor ID
- 1994/2424
- Conditions
- Turner Syndrome
- Keywords
- Turner Syndrome, bone mineral density, estrogen replacement therapy, dual energy x-ray absorptiometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 1994
- Primary completion
- Oct 1996 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with Turner syndrome |
| 2 | – | –Healthy control women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Turner syndrome
Key inclusion criteria (1 listed)
- Turner syndrome verified by karyotyping
Key exclusion criteria (4 listed)
- untreated hypothyroidism or hyperthyroidism
- present or past malignant diseases
- clinical liver disease
- treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2008; AzTrials last refreshed its copy on 8 Nov 2026.