Danish Osteoporosis Prevention Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Danish Osteoporosis Prevention Study|
- Bone mineral density
- Breast cancer
- Menopausal symptoms
|Study Start Date:||October 1990|
|Estimated Study Completion Date:||December 2003|
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.
|The Osteoporosis Clinic, Aarhus Sygehus|
|Aarhus, Denmark, DK-8000|
|Study Chair:||Leif Mosekilde, Professor MD DrMedSc||department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark|
|Study Director:||Jens Erik Beck Jensen, MD PhD||The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen|
|Study Director:||Peder Charles, MD DrMedSc||Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark|
|Study Director:||Stig Pors Nielsen, MD DrMedSc||Department of Clinical Physiology and Nuclear Medicine, Hillerød Hospital, Hillerød, Denmark|
|Study Director:||Henning Beck Nielsen, MD DrMedSc||Department of Endocrinology, Odense University Hospital, Odense, Denmark|
|Study Director:||Kim Brixen, MD PhD||Department of Endocrinology, Odense University Hospital, Odense, Denmark|
|Study Director:||Ole Helmer Sørensen, MD DrMedSc||The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark|