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.
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.
Status: Completed (Phase 4). Started on October 1st, 1990.
Enrollment: 2000 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Open Label
- Primary Purpose: Prevention
Conditions:
Interventions:
- Drug: Hormone replacement therapy
Eligibility
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
- Gender
Female
- Mininum Age
45 Years
- Maximum Age
58 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: University of Aarhus
Authority: Denmark: National Board of Health
Locations
-
The Osteoporosis Clinic, Aarhus Sygehus
Aarhus
DK-8000
Denmark
Officials
Leif Mosekilde, Professor MD DrMedSc (Study Chair, department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark)
Jens Erik Beck Jensen, MD PhD (Study Director, The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen)
Peder Charles, MD DrMedSc (Study Director, Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark)
Stig Pors Nielsen, MD DrMedSc (Study Director, Department of Clinical Physiology and Nuclear Medicine, Hiller��d Hospital, Hiller��d, Denmark)
Henning Beck Nielsen, MD DrMedSc (Study Director, Department of Endocrinology, Odense University Hospital, Odense, Denmark)
Kim Brixen, MD PhD (Study Director, Department of Endocrinology, Odense University Hospital, Odense, Denmark)
Ole Helmer S��rensen, MD DrMedSc (Study Director, The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark)
Sponsors
University of Aarhus (Lead Sponsor)
Karen Elise Jensens Foundation (Collaborator)
Novo Nordisk (Collaborator)
LEO Pharma (Collaborator)
Novartis (Collaborator)
References
None.
Links
None.
- Date Verified
- September 1st, 2009
- First Received
- September 3rd, 2009
- Last Changed
- September 3rd, 2009
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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