Bone Status and Insulin Resistance in Hirsutism
Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism
1 other identifier
observational
50
1 country
1
Brief Summary
The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women. Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients. All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition). The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2002
Longer than P75 for all trials
1 active site
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
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJune 24, 2008
June 1, 2008
5 years
September 1, 2005
June 23, 2008
Conditions
Keywords
Eligibility Criteria
hirsute patients vs. controls
You may qualify if:
- Hirsute subjects:
- Belonging to group 1 or 2.
- Age: 20-46
- Hirsute score: \>7
- Written informed consent
- Control group:
- Age: 20-46
- Hirsute score: 0 (without razing)
- Regular menses
- Written informed consent
You may not qualify if:
- Previous cosmetic treatment for hirsutism.
- Use of contraceptive pill (within the past 6 months)
- Systemic steroid treatment \> 6 weeks (ever)
- Age above 46 years/post menopause (increased FSH)
- Recognized diabetes mellitus or other endocrine disease
- Eating disorder
- Serious, treatment demanding disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Research Center
Odense, Funen, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorte Glintborg, MD
Odense University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
January 1, 2002
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
June 24, 2008
Record last verified: 2008-06