The goal of this randomized-controlled trial is to compare the effect of rhythmic estrogen
treatment to continuous estrogen treatment on bone turnover in healthy postmenopausal women.
The main question it aims to answer are:
• Does rhythmic estrogen lead to increased bone formation in healthy postmenopausal women,
compared to continuous estrogen?
Participants will receive one of the following treatments for a duration of 16 weeks:
- Rhythmic estradiol: Alternating 4-week cycles consisting of transdermal 17-β-estradiol
25μg/24hrs for two weeks, followed by two weeks of transdermal 17-β-estradiol 50μg/24hrs.
Estradiol therapy will be combined with continuous oral micronized progesterone 100mg once
daily.
- Low-dose continuous estradiol: Continuous transdermal 17-β-estradiol 25μg/24hrs,
combined with continuous oral micronized progesterone 100mg daily once daily.
- Standard-dose continuous estradiol: Continuous transdermal 17-β-estradiol 50μg/24hrs,
combined with continuous oral micronized progesterone 100mg daily once daily.
If there is a comparison group: Researchers will compare rhythmic estradiol to continuous
estradiol to see if rhythmic estradiol improves bone formation in postmenopausal women.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)