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Completed

NCT Number: NCT04203212

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

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

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Key information

Conditions

Endometriosis Bone Density Bone Metabolism Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Muscle Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

424 General Military Hospital

Thessaloniki, 56429, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Premenopausal women with surgically verified endometriosis

Exclusion criteria

  • Secondary osteoporosis
  • diseases or conditions that could affect bone and/or muscle metabolism
  • any medications that could affect bone and/or muscle metabolism

Treatment and study plan

Goserelin acetate

Drug

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

Other names: GnRH analog

Primary outcomes

  1. lumbar spine BMD

    Time frame: between baseline and 6 months after goserelin initiation

    Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry

  2. lumbar spine BMD

    Time frame: between baseline and 6 months after goserelin discontinuation

    Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry

Secondary outcomes

  1. femoral neck BMD

    Time frame: between baseline and 6 months after goserelin initiation

    Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry

  2. femoral neck BMD

    Time frame: between baseline and 6 months after goserelin discontinuation

    Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry

  3. sclerostin

    Time frame: 0,6,12 months

    bone metabolism parameter measured in sera

  4. periostin

    Time frame: 0,3,6,12 months

    bone metabolism parameter measured in sera

  5. irisin

    Time frame: 0,3,6,12 months

    myokine measured in sera

  6. follistatin

    Time frame: 0,3,6,12 months

    myokine measured in sera

  7. activin-A

    Time frame: 0,3,6,12 months

    myokine measured in sera

  8. noggin

    Time frame: 0,3,6,12 months

    BMP inhibitor measured in sera

  9. miRs

    Time frame: 0,6,12 months

    bone related microRNAs measured in sera

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Collaborators

  • 251 Hellenic Air Force & VA General Hospital
  • Aristotle University Of Thessaloniki

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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