Rhythmic Estradiol and Bone Health

Last updated: February 3, 2025
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Completed

Phase

4

Condition

Menopause

Osteoporosis

Treatment

Estradiol patch

Progesterone

Clinical Study ID

NCT05903820
NL83336.018.23
  • Ages 45-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal, defined as final menstrual cycle more than 1 years prior toinclusion and FSH>30 IU/L

  • Final menstrual cycle < 10 years prior to inclusion

Exclusion

Exclusion Criteria:

  • Contra-indication for estrogen and/or progesterone therapy

  • First-grade family member with inherited thrombophilia or history of venousthromboembolism under the age of 60 years

  • Hysterectomy

  • Premature menopause (menopause age <40 years)

  • Known hypersensitivity to the excipients in the estradiol patch or progesteronecapsule

  • Hormonal contraception or hormone replacement therapy use (estradiol with or withoutprogesterone) in the past 12 months

  • Presence or history of any clinically relevant metabolic, endocrinological, hepatic,renal, cardiovascular, gastrointestinal, or respiratory conditions, history of bonedisease or bone marrow disease, known vitamin D deficiency (25-OH vitamin D <30nmol/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 ortopical medication

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Estradiol patch
Phase: 4
Study Start date:
July 19, 2023
Estimated Completion Date:
October 28, 2024

Connect with a study center

  • Amsterdam UMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

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