Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2000 participants
INTERVENTIONAL
1990-10-31
2003-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Hormone replacement therapy
Eligibility Criteria
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Inclusion Criteria
* Three to 24 month past last menstrual bleeding
* Hysterectomised women aged 45-52 years and having elevated FSH
Exclusion Criteria
* 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
45 Years
58 Years
FEMALE
Yes
Sponsors
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Karen Elise Jensen Foundation
OTHER
Novo Nordisk A/S
INDUSTRY
LEO Pharma
INDUSTRY
Novartis
INDUSTRY
University of Aarhus
OTHER
Principal Investigators
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Leif Mosekilde, Professor MD DrMedSc
Role: STUDY_CHAIR
department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Jens Erik Beck Jensen, MD PhD
Role: STUDY_DIRECTOR
The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen
Peder Charles, MD DrMedSc
Role: STUDY_DIRECTOR
Department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark
Stig Pors Nielsen, MD DrMedSc
Role: STUDY_DIRECTOR
Department of Clinical Physiology and Nuclear Medicine, Hillerød Hospital, Hillerød, Denmark
Henning Beck Nielsen, MD DrMedSc
Role: STUDY_DIRECTOR
Odense University Hospital
Kim Brixen, MD PhD
Role: STUDY_DIRECTOR
Odense University Hospital
Ole Helmer Sørensen, MD DrMedSc
Role: STUDY_DIRECTOR
The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark
Locations
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The Osteoporosis Clinic, Aarhus Sygehus
Aarhus, , Denmark
Countries
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References
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Mosekilde L, Beck-Nielsen H, Sorensen OH, Nielsen SP, Charles P, Vestergaard P, Hermann AP, Gram J, Hansen TB, Abrahamsen B, Ebbesen EN, Stilgren L, Jensen LB, Brot C, Hansen B, Tofteng CL, Eiken P, Kolthoff N. Hormonal replacement therapy reduces forearm fracture incidence in recent postmenopausal women - results of the Danish Osteoporosis Prevention Study. Maturitas. 2000 Oct 31;36(3):181-93. doi: 10.1016/s0378-5122(00)00158-4.
Torekov SS, Harslof T, Rejnmark L, Eiken P, Jensen JB, Herman AP, Hansen T, Pedersen O, Holst JJ, Langdahl BL. A functional amino acid substitution in the glucose-dependent insulinotropic polypeptide receptor (GIPR) gene is associated with lower bone mineral density and increased fracture risk. J Clin Endocrinol Metab. 2014 Apr;99(4):E729-33. doi: 10.1210/jc.2013-3766. Epub 2014 Jan 21.
Schierbeck LL, Rejnmark L, Tofteng CL, Stilgren L, Eiken P, Mosekilde L, Kober L, Jensen JE. Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women: randomised trial. BMJ. 2012 Oct 9;345:e6409. doi: 10.1136/bmj.e6409.
Other Identifiers
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DOPS
Identifier Type: -
Identifier Source: secondary_id
1990/1821
Identifier Type: -
Identifier Source: org_study_id
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