Danish Osteoporosis Prevention Study
|ClinicalTrials.gov Identifier: NCT00252408|
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : September 4, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Hormone replacement therapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Danish Osteoporosis Prevention Study|
|Study Start Date :||October 1990|
|Study Completion Date :||December 2003|
- Bone mineral density
- Breast cancer
- Menopausal symptoms
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252408
|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|