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

Completed

• Conditions: Muscle; Endometriosis; Bone Metabolism; Bone Density
• Interventions: Drug: Goserelin Acetate

• Registration Number: NCT04203212
• Lead Sponsor: 424 General Military Hospital

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometriosis Group	Goserelin Acetate	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.

Primary Outcome Measures

Name	Time	Method
lumbar spine BMD	between baseline and 6 months after goserelin discontinuation	Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry

Secondary Outcome Measures

Name	Time	Method
femoral neck BMD	between baseline and 6 months after goserelin discontinuation	Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry
sclerostin	0,6,12 months	bone metabolism parameter measured in sera
follistatin	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
activin-A	0,3,6,12 months	myokine 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

Trial Locations

Locations (1)

424 General Military Hospital; 🇬🇷 Thessaloníki, Greece