preventie osteoporose Osteoporosis prevention
Conditions
Interventions
Each treatment arm has a treatment duration of 16 weeks (4 cycles of 4 weeks).
A transdermal treatment regimen will be implemented. The risk venous
thromboembolism is not elevated in transdermal est
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Postmenopausal, defined as final menstrual cycle more than 12 months prior to inclusion and FSH>30 IU/L - Final menstrual cycle
Exclusion criteria
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 =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoint is the interaction between treatment and time on serum P1NP levels. (Does the change over time differ between the treatment arms?). The primary outcome will be measured every two weeks from baseline until 16 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The secondary endpoint is the interaction between treatment and time on serum CTX levels. (Does the change over time differ between the treatment arms?) The outcome will be measured every two weeks from baseline until 16 weeks of treatment. 2. Mean change of fasting glucose, fasting insulin, 2-hour post OGTT glucose and insulin and liver steatosis (CAP score) after 16 weeks of treatment. These parameters will be measured at baseline and after 16 weeks. 3. Sleep quality (PSQI) and chronotype (MCTQ) and menopausal symptoms (GCS) after 16 weeks in relation to baseline. 4. In a subgroup: To assess the effect of low-dose rhythmic transdermal 17-β- estradiol versus continuous low-dose and standard-dose continuous transdermal 17-β-estradiol on 17-β-estradiol transcriptional regulation in adipose tissue using ChipSeq and RNA seq analysis (hypothesis-generating). | — |
Countries
Netherlands
Outcome results
None listed