BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH

Study Overview
=================
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.

Official Title
-----------------
Bone Mineral Density Alterations and Correlations With Bone and Muscle Metabolism Parameters During Menstrual Cessation Due to GnRH Therapy and After Menstrual Restoration

Conditions
-----------------
Endometriosis, Bone Density, Muscle, Bone Metabolism

Intervention / Treatment
-----------------
* Drug: Goserelin Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal women with surgically verified endometriosis Exclusion Criteria: Secondary osteoporosis diseases or conditions that could affect bone and/or muscle metabolism any medications that could affect bone and/or muscle metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometriosis Group<br>20 premenopausal women with surgically verified endometriosis who 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. | Drug: Goserelin Acetate<br>* Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months<br>* Other names: GnRH analog;|
| Control Group<br>20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lumbar spine BMD | Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry | between baseline and 6 months after goserelin initiation | 
| lumbar spine BMD | Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry | between baseline and 6 months after goserelin discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| femoral neck BMD | Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry | between baseline and 6 months after goserelin initiation | 
| femoral neck BMD | Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry | between baseline and 6 months after goserelin discontinuation | 
| sclerostin | bone metabolism parameter measured in sera | 0,6,12 months | 
| periostin | bone metabolism parameter measured in sera | 0,3,6,12 months | 
| irisin | myokine measured in sera | 0,3,6,12 months | 
| follistatin | myokine measured in sera | 0,3,6,12 months | 
| activin-A | myokine measured in sera | 0,3,6,12 months | 
| noggin | BMP inhibitor measured in sera | 0,3,6,12 months | 
| miRs | bone related microRNAs measured in sera | 0,6,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, bone mineral density, myokines, sclerotin, periostin