Danish Osteoporosis Prevention Study
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Leif Mosekilde, Professor MD DrMedSc
department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Denmark: Danish Medicines Agency