Spots Global Cancer Trial Database for Danish Osteoporosis Prevention Study
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Trial Identification
Brief Title: Danish Osteoporosis Prevention Study
Official Title: Danish Osteoporosis Prevention Study
Study ID: NCT00252408
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed 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.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
The Osteoporosis Clinic, Aarhus Sygehus, Aarhus, , Denmark
Contact Details
Name: Leif Mosekilde, Professor MD DrMedSc
Affiliation: department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Role: STUDY_CHAIR
Name: Jens Erik Beck Jensen, MD PhD
Affiliation: The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen
Role: STUDY_DIRECTOR
Name: Peder Charles, MD DrMedSc
Affiliation: Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Role: STUDY_DIRECTOR
Name: Stig Pors Nielsen, MD DrMedSc
Affiliation: Department of Clinical Physiology and Nuclear Medicine, Hillerød Hospital, Hillerød, Denmark
Role: STUDY_DIRECTOR
Name: Henning Beck Nielsen, MD DrMedSc
Affiliation: Odense University Hospital
Role: STUDY_DIRECTOR
Name: Kim Brixen, MD PhD
Affiliation: Odense University Hospital
Role: STUDY_DIRECTOR
Name: Ole Helmer Sørensen, MD DrMedSc
Affiliation: The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark
Role: STUDY_DIRECTOR
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