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

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

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

Study Overview

• Status: Completed
• Conditions: Endometriosis; Bone Density; Muscle; Bone Metabolism
• Intervention / Treatment: Drug: Goserelin Acetate

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece, 56429
    • 424 General Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endometriosis Group; 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; Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months; Other Names: GnRH analog
Control Group; 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

Collaborators and Investigators

• Sponsor: 424 General Military Hospital
• Collaborators: Aristotle University Of Thessaloniki; 251 Hellenic Air Force & VA General Hospital
• Investigators: Principal Investigator: Athanasios Anastasilakis, phD, 424 General Military Hospital

Publications and helpful links

General Publications

• Paoletti AM, Serra GG, Cagnacci A, Vacca AM, Guerriero S, Solla E, Melis GB. Spontaneous reversibility of bone loss induced by gonadotropin-releasing hormone analog treatment. Fertil Steril. 1996 Apr;65(4):707-10.
• Waibel-Treber S, Minne HW, Scharla SH, Bremen T, Ziegler R, Leyendecker G. Reversible bone loss in women treated with GnRH-agonists for endometriosis and uterine leiomyoma. Hum Reprod. 1989 May;4(4):384-8. doi: 10.1093/oxfordjournals.humrep.a136912.
• Taga M, Minaguchi H. Reduction of bone mineral density by gonadotropin-releasing hormone agonist, nafarelin, is not completely reversible at 6 months after the cessation of administration. Acta Obstet Gynecol Scand. 1996 Feb;75(2):162-5. doi: 10.3109/00016349609033310.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: endometriosis; bone mineral density; myokines; sclerotin; periostin
• Additional Relevant MeSH Terms: Endometriosis; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: Menomyobone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: After study results being accepted for publication they will be available for everyone that might ask for them

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No