Research with human participants

Overview of medical research in the Netherlands

Estrogen and bone marrow adiposity.

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON21671

Source

NTR

Brief title

E2BMFat part 2

Health condition

Osteoporosis

Sponsors and support

Primary sponsor :
Academic Medical Center (AMC) Amsterdam
Source(s) of monetary or material Support :
Academic Medical Center (AMC) Amsterdam

Intervention

Outcome measures

Primary outcome

The role of estrogen in dynamic changes in bone marrow adiposity these changes.

Secondary outcome

NA

Background summary

Bone 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.

Study objective

Estrogen plays an role in the dynamic changes in bone marrow adiposity.

Study design

Study 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.

Intervention

Estrogen (Zumenon 1dd 2 mg) day 14 to day 28

Public
Meibergdreef 9, Room F5-165
P.H.L.T. Bisschop
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666071
p.h.bisschop@amc.uva.nl
Scientific
Meibergdreef 9, Room F5-165
P.H.L.T. Bisschop
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666071
p.h.bisschop@amc.uva.nl

Inclusion criteria

Postmenopausal 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)

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
6
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

ID: 39889
Bron: ToetsingOnline
Titel: Dynamic Changes in Bone Marrow Adiposity and the Role of Estrogen

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL4390
NTR-old NTR4521
CCMO NL40171.018.12
OMON NL-OMON39889

Summary results

NA