The effect of low-dose rhythmic 17-β-estradiol administration on bone turnover in postmenopausal wome

Phase 4

Recruiting

• Conditions: preventie osteoporose; Osteoporosis prevention; 10005959

• Registration Number: NL-OMON53396
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

- Postmenopausal, defined as final menstrual cycle more than 12 months prior to
inclusion and FSH>30 IU/L
- Final menstrual cycle < 10 years prior to inclusion
- Age 45-60 years

Exclusion Criteria

• Contra-indication for estrogen and/or progesterone therapy: Presence or
suspicion or history of breast cancer, endometrial cancer, ovarian cancer,
presence or history of venous thromboembolism, arterial thrombosis (e.g.
myocardial infarction, angina pectoris) inherited or acquired thrombophilia,
presence of liver disease, untreated endometrial hyperplasia, abnormal vaginal
bleeding, porphyria, uncontrolled or severe hypertension)
• First-grade family member with inherited thrombophilia or history of VTE
under the age of 60 years
• Hysterectomy
• Premature menopause (menopause age <40 years)
• Known hypersensitivity to the excipients in the estradiol patch: acrylate
copolymer, polyethylene terephthalate, a-tocopherol, soy allergy or peanut
allergy (component of 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
• For adipose tissue biopsy: anticoagulant treatment, allergy to lidocaine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The endpoint is the interaction between treatment and time on serum P1NP<br /><br>levels. (Does the change over time differ between the treatment arms?). The<br /><br>primary outcome will be measured every two weeks from baseline until 16 weeks<br /><br>of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The secondary endpoint is the interaction between treatment and time on<br /><br>serum CTX levels. (Does the change over time differ between the treatment<br /><br>arms?) The outcome will be measured every two weeks from baseline until 16<br /><br>weeks of treatment.<br /><br>2. Mean change of fasting glucose, fasting insulin, 2-hour post OGTT glucose<br /><br>and insulin and liver steatosis (CAP score) after 16 weeks of treatment. These<br /><br>parameters will be measured at baseline and after 16 weeks.<br /><br>3. Sleep quality (PSQI) and chronotype (MCTQ) and menopausal symptoms (GCS)<br /><br>after 16 weeks in relation to baseline.<br /><br>4. In a subgroup: To assess the effect of low-dose rhythmic transdermal 17-&beta;-<br /><br>estradiol versus continuous low-dose and standard-dose continuous transdermal<br /><br>17-&beta;-estradiol on 17-&beta;-estradiol transcriptional regulation in adipose tissue<br /><br>using ChipSeq and RNA seq analysis (hypothesis-generating).</p><br>