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
Verified date | January 2021 |
Source | 424 General Military Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Greece | 424 General Military Hospital | Thessaloníki |
Lead Sponsor | Collaborator |
---|---|
424 General Military Hospital | 251 Hellenic Air Force & VA General Hospital, Aristotle University Of Thessaloniki |
Greece,
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
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 |
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