Phase 4CompletedAge-related condition
Rhythmic Estradiol and Bone Health (REBEL)
The Effect of Low-dose Rhythmic 17-β-estradiol Administration on Bone Turnover in Postmenopausal Women
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic or other)
- Enrollment
- 48 enrolled
- Conditions
- Osteoporosis Risk; Menopause
- Interventions
- Estradiol patch; Progesterone
- Ages
- adults
- Registry
- NCT05903820
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Serum P1NP
History
Last registry update
Study completion
Primary completion
Started
Registered