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Estrogen and bone marrow adiposity.


- candidate number17506
- NTR NumberNTR4521
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-apr-2014
- Secondary IDsNL40171.018.12 
- Public TitleEstrogen and bone marrow adiposity.
- Scientific TitleDynamic Changes in Bone Marrow Adiposity and the Role of Estrogen
- ACRONYME2BMFat part 2
- hypothesisEstrogen plays an role in the dynamic changes in bone marrow adiposity.
- Healt Condition(s) or Problem(s) studiedOsteoporosis, Estrogens
- Inclusion criteriaPostmenopausal women
- Exclusion criteria contraindications to MRI scanning as determined by a standard checklist
use of bone-modifying or adipose tissue-modifying drugs
bone/adipose tissue/bone marrow diseases
contraindications to estrogen treatment (history of hormone-sensitive cancer, VTE, unexplained vaginal bleeding, endometrial hyperplasia, endometriosis, arterial thrombo-embolic diseases, acute hepatic disease or liver enzyme disorders, porfyria or known hypersensitivity to components of zumenon)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 14-mrt-2014
- planned closingdate27-apr-2014
- Target number of participants6
- InterventionsEstrogen (Zumenon 1dd 2 mg) day 14 to day 28
- Primary outcomeThe role of estrogen in dynamic changes in bone marrow adiposity these changes.
- Secondary outcomeNA
- TimepointsStudy duration of 6 weeks, with intervention form day 14 to 28.
MRI to measure BM adiposity and bloodsamples at day 0/7/14/21/28/35/42.
- Trial web siteNA
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. P.H.L.T. Bisschop
- CONTACT for SCIENTIFIC QUERIESDr. P.H.L.T. Bisschop
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsNA
- Brief summaryBone marrow consists mainly of bone cells, fat cells and hematopoietic cells. The gradual decrease of bone and hematopoietic fraction and the increase of fat fraction in the bone marrow with ageing and the same rapid changes following menopause have long been recognized. A recent and unexpected observation is that these parameters show dynamic changes over the course of days during a normal menstrual cycle. A common denominator for both phenomena might be estrogen status.
- Main changes (audit trail)
- RECORD16-apr-2014 - 22-mei-2015


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