Bone Status and Insulin Resistance in Hirsutism

Hirsutism Clinical Trial

Official title:

Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143052
• Other study ID #: 003
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: June 23, 2008
• Start date: January 2002
• Est. completion date: January 2007

Study information

• Verified date: June 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 46 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hirsutism

Locations

Country	Name	City	State
Denmark	Diabetes Research Center	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark,