Osteoporosis
Conditions
Keywords
Fracture, Osteoporosis, Bone mineral density, Hormone replacement therapy, Estrogen, Breast cancer
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.
Interventions
DRUGHormone replacement therapy
Sponsors
Karen Elise Jensen Foundation
Novo Nordisk A/S
LEO Pharma
Novartis
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 58 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture | — |
| Bone mineral density | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast cancer | — |
| Menopausal symptoms | — |
Countries
Denmark
Outcome results
None listed