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|---|---|---|---|
| DOPS |
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| Name | Class |
|---|---|
| Karen Elise Jensen Foundation | OTHER |
| Novo Nordisk A/S | INDUSTRY |
| LEO Pharma | INDUSTRY |
| Novartis |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hormone replacement therapy | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture | ||
| Bone mineral density |
| Measure | Description | Time Frame |
|---|---|---|
| Breast cancer | ||
| Menopausal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leif Mosekilde, Professor MD DrMedSc | department of Endocrinology and Metabolism C, Aarhus University Hospital, Denmark | Study Chair |
| 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 | Odense University Hospital | Study Director |
| Kim Brixen, MD PhD | Odense University Hospital | Study Director |
| Ole Helmer Sørensen, MD DrMedSc | The Osteoporosis Clinic, Hvidovre Hospital, Copenhagen, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Osteoporosis Clinic, Aarhus Sygehus | Aarhus | DK-8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11063900 | Result | 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. | |
| 24446656 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D050723 | Fractures, Bone |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| INDUSTRY |
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| Derived |
| 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. |
| 23048011 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |