Status:

COMPLETED

Danish Osteoporosis Prevention Study

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

Karen Elise Jensen Foundation

Novo Nordisk A/S

Conditions:

Osteoporosis

Eligibility:

FEMALE

45-58 years

Phase:

PHASE4

Brief Summary

Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in early postmenopausal women. The project was initiated in 1990, and the inclusion ended in 1993. A total of...

Detailed Description

Aim: To study the ability of hormone replacement early after menopause on risk of fractures and changes in bone mineral density, and side effects. The project was designed as a comprehensive cohort t...

Eligibility Criteria

Inclusion

  • Women aged 45-58 years with an intact uterus
  • Three to 24 month past last menstrual bleeding
  • Hysterectomised women aged 45-52 years and having elevated FSH

Exclusion

  • Metaboliv bone disease including osteoporosis defined as non-traumatic vertebral fractures on X-ray
  • Current estrogen use or estrogen use within the past three month
  • Current or past treatment with glucocorticoids for more than 6 month
  • Current or past malignancy
  • Newly diagnosed or uncontrolled chronic disease
  • Alcohol or drug addiction

Key Trial Info

Start Date :

October 1 1990

Trial Type :

INTERVENTIONAL

End Date :

December 1 2003

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT00252408

Start Date

October 1 1990

End Date

December 1 2003

Last Update

September 4 2009

Active Locations (1)

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1

The Osteoporosis Clinic, Aarhus Sygehus

Aarhus, Denmark, DK-8000