Clinical trial NCT04203212: BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Bone Density
Muscle
Bone Metabolism
Keywords: endometriosis
bone mineral density
myokines
sclerotin
periostin
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
Collaborators: name: 251 Hellenic Air Force & VA General Hospital
name: Aristotle University Of Thessaloniki
First posted: 2019-12-18
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: lumbar spine BMD
timeFrame: between baseline and 6 months after goserelin initiation
measure: lumbar spine BMD
timeFrame: between baseline and 6 months after goserelin discontinuation
Secondary outcomes:
measure: femoral neck BMD
timeFrame: between baseline and 6 months after goserelin initiation
measure: femoral neck BMD
timeFrame: between baseline and 6 months after goserelin discontinuation
measure: sclerostin
timeFrame: 0,6,12 months
measure: periostin
timeFrame: 0,3,6,12 months
measure: irisin
timeFrame: 0,3,6,12 months
measure: follistatin
timeFrame: 0,3,6,12 months
measure: activin-A
timeFrame: 0,3,6,12 months
measure: noggin
timeFrame: 0,3,6,12 months
measure: miRs
timeFrame: 0,6,12 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: 424 General Military Hospital
Study officials:
affiliation: 424 General Military Hospital
name: Athanasios Anastasilakis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1093/oxfordjournals.humrep.a136912.
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. doi: 10.3109/00016349609033310.