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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203212
• Other study ID #: Menomyobone
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Density
• Bone Metabolism
• Endometriosis
• Muscle

Intervention

Drug:
• Goserelin Acetate
Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months

Locations

Country	Name	City	State
Greece	424 General Military Hospital	Thessaloníki

Sponsors (3)

Lead Sponsor	Collaborator
424 General Military Hospital	251 Hellenic Air Force & VA General Hospital, Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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