To investigate the dynamic changes in bone marrow adiposity during the menstrual cycle as assessed by Dixon*s Quantitative Chemical Shift Imaging (QCSI) measurements and to determine the role of estrogen in these changes.
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the dynamic changes in bone marrow adiposity as
assessed by QCSI measurements and the correlation of these changes to changes
in hormones involved in the menstrual cycle (follicle stimulating hormone,
luteinizing hormone, progesterone and estradiol).
Secondary outcome
NA
Background summary
Bone marrow (BM) bone volume and BM adipose tissue volume show an inverse
correlation associated with age and menopausal status. 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
To investigate the dynamic changes in bone marrow adiposity during the
menstrual cycle as assessed by Dixon*s Quantitative Chemical Shift Imaging
(QCSI) measurements and to determine the role of estrogen in these changes.
Study design
Part 1: Observational cohort study
Part 2: Intervention trial
Intervention
Part 1: no intervention
Part 2: administration of estrogen (Zumenon 1dd 2 mg) during 14 days
Study burden and risks
Estrogen treatment is associated with an increase in hormone-sensitive cancers,
cardiovascular disease (CVD) and venous thrombo-embolism (VTE). However, large
meta-analyses confirm that these effects occur after prolonged treatment (>1
year), whereas this study discontinues treatment after 14 days. Therefore the
risks seem insignificant. The QCSI procedure is a non-invasive, non-ionizing
imaging technique without contrast administration. This procedure will be
performed 7 or 9 times and will take approximately 30 minutes per procedure.
Venous blood sampling will be performed 7 or 9 times and the total amount of
blood will not exceed 250 ml. Risks associated with venous blood sampling are
negligible. Dual energy X-ray absorptiometry will be performed 3 times, the
radiation exposure poses a negligible risk.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
female sex
regular menstrual cycle and age 18 to 50 years OR 1-5 years postmenopausal
Exclusion criteria
contraindications to MRI scanning
use of bone-modifying or adipose tissue-modifying drugs
use of hormonal contraception
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL40171.018.12 |
| OMON | NL-OMON21671 |