Rhythmic Estradiol and Bone Health (REBEL)
Osteoporosis Risk, Menopause
About this trial
This is an interventional prevention trial for Osteoporosis Risk
Eligibility Criteria
Inclusion Criteria: Postmenopausal, defined as final menstrual cycle more than 1 years prior to inclusion and FSH>30 IU/L Final menstrual cycle < 10 years prior to inclusion Exclusion Criteria: Contra-indication for estrogen and/or progesterone therapy First-grade family member with inherited thrombophilia or history of venous thromboembolism under the age of 60 years Hysterectomy Premature menopause (menopause age <40 years) Known hypersensitivity to the excipients in the estradiol patch or progesterone capsule Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) in the past 12 months Presence or history of any clinically relevant metabolic, endocrinological, hepatic, renal, cardiovascular, gastrointestinal, or respiratory conditions, history of bone disease or bone marrow disease, known vitamin D deficiency (25-OH vitamin D <30 nmol/L) Recent fracture (<12 months) BMI <20 or BMI ≥30 Use of drugs including herbal medicine known to affect bone metabolism (e.g. corticosteroids) or to interfere with cytochrome P450 enzyme (CYP) pathways. Exceptions are occasional use of paracetamol, ibuprofen, acetylsalicylic acid or topical medication
Sites / Locations
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
Continuous estradiol 50 mcg/day
Continuous estradiol 25 mcg/day
Rhythmic estradiol 25-50 mcg/day
The continuous standard-dose 17-β-estradiol group will receive the standard therapy for prevention of osteoporosis. A transdermal patch that releases 50ug/24 hrs of 17-β-estradiol will be administered continuously during the 16 weeks of treatment.
The continuous low-dose 17-β-estradiol group will receive a transdermal patch that releases 25ug/24 hrs of 17-β-estradiol administered continuously during the 16 weeks of treatment.
The rhythmic 17-β-estradiol group will receive a transdermal patch for two weeks that releases 25ug/24hrs of 17-β-estradiol, and a patch of 50ug/24hrs for 2 weeks in each 4-week cycle.