Danish Osteoporosis Prevention Study

University of Aarhus

Status and phase

Completed

Phase 4

Conditions

Osteoporosis

Treatments

Drug: Hormone replacement therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00252408

1990/1821

DOPS

Details and patient eligibility

About

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.

Full 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 trial. One group accepted randomisation, and was randomised to hormone replacement therapy (HRT) or not (no placebo used).

502 were randomised to HRT, and 504 were randomised to no HRT) One group was allowed to choose HRT or not. A total of 221 chose HRT, and 789 chose no HRT.

First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and oral continuous oestradiol in hysterectomised women.

The study was initiated in 1990, and inclusion ended in 1993.

Sex

Female

Ages

45 to 58 years old

Volunteers

Accepts Healthy Volunteers

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