Bone Density, Bone Metabolism, Endometriosis, Muscle
Conditions
Keywords
endometriosis, bone mineral density, myokines, sclerotin, periostin
Brief summary
The investigators aim to investigate the effect of menstrual cessation in women with endometriosis treated with GnRH analogs for 6 months on bone mineral density and bone and muscle metabolism parameters and subsequently the effects of menstrual restoration after GnRH analogs discontinuation on the above measured parameters
Detailed description
Prospective, open-label, controlled 12month observational study Premenopausal women with surgically verified endometriosis will receive goserelin 1 injection per month for 6 months. Subsequently goserelin will be discontinued and patients will be monitored for another 6 months after menstrual restoration. Age- and BMI-matched premenopausal, health women will serve as controls. Controls will receive no treatment.
Interventions
DRUGGoserelin Acetate
Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months
Sponsors
251 Hellenic Air Force & VA General Hospital
Aristotle University Of Thessaloniki
424 General Military Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Premenopausal women with surgically verified endometriosis
Exclusion criteria
1. Secondary osteoporosis 2. diseases or conditions that could affect bone and/or muscle metabolism 3. any medications that could affect bone and/or muscle metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lumbar spine BMD | between baseline and 6 months after goserelin initiation | Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sclerostin | 0,6,12 months | bone metabolism parameter measured in sera |
| periostin | 0,3,6,12 months | bone metabolism parameter measured in sera |
| irisin | 0,3,6,12 months | myokine measured in sera |
| femoral neck BMD | between baseline and 6 months after goserelin initiation | Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry |
| activin-A | 0,3,6,12 months | myokine measured in sera |
| noggin | 0,3,6,12 months | BMP inhibitor measured in sera |
| miRs | 0,6,12 months | bone related microRNAs measured in sera |
| follistatin | 0,3,6,12 months | myokine measured in sera |
Countries
Greece
Outcome results
None listed