ClinicalTrials.gg
CompletedNCT00143052Updated Jun 24, 2008

Bone Status and Insulin Resistance in Hirsutism

An observational study in Hirsutism, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to female participants aged 20 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-24.

Sponsored by Odense University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 46 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hirsutism

Keywords

  • Hirsutism
  • Bone status
  • Androgens
  • insulin
03

In context

Hirsutism

41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.

This study's enrollment of 50 is below the median of 206 across 14 observational studies indexed under Hirsutism.

Browse Hirsutism studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Study population

hirsute patients vs. controls

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Hirsute subjects:

  • Belonging to group 1 or 2.
  • Age: 20-46
  • Hirsute score: >7
  • Written

Control group:

  • Age: 20-46
  • Hirsute score: 0 (without razing)
  • Regular menses
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Previous cosmetic treatment for hirsutism.
  • Use of pill (within the past 6 months)
  • Systemic 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
06

Study locations

1 site
  • Diabetes Research Center
    Odense, Funen 5000, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00143052
First posted
Sep 2, 2005
Start date
Jan 2002
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Jun 24, 2008

Study contacts

Dorte Glintborg, MD
principal investigator · Odense University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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