Danish Osteoporosis Prevention Study

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: Female

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 2,016 early postmenopausal women were divided into two groups: The first group accepted randomisation to HRT or not, and the second group was allowed to choose HRT or not.

The study was not blinded. Main measurements were fracture risk over 20 years, changes in bone mineral density over 20 years, and side effects, mainly breast cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Karen Elise Jensen Foundation; LEO Pharma; Novartis; Novo Nordisk A/S
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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