Trial · Observational

CompletedPhase not statedRegistry data

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

NCTNCT04203212Other idMenomyobone

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 41 participants (actual)
Sponsor: 424 General Military Hospital · Other
Design: Not stated
Countries: 1 country
Greece
Start: 1 Oct 2019
Primary completion: 1 Dec 2020
Completion: 31 Dec 2020
First posted: 18 Dec 2019
Last update posted: 12 Jan 2021
Conditions: Endometriosis · Bone Density · Muscle · Bone Metabolism

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021

Ph –
BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH
NCT04203212
1 Oct 2019 to 31 Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Goserelin AcetateDrug

Arms2

Other
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.
Other
Control Group
20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months.

Primary outcomes2

Outcomes the sponsor listed as primary.

lumbar spine BMD
Time frame · between baseline and 6 months after goserelin initiation
Registry description
Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry
lumbar spine BMD
Time frame · between baseline and 6 months after goserelin discontinuation
Registry description
Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry

Secondary outcomes(9)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 1996

3 results

Spontaneous reversibility of bone loss induced by gonadotropin-releasing hormone analog treatment.

Paoletti et al. 1996Fertility and sterilitycited by 44

PMID 8654625DOI 10.1016/s0015-0282(16)58200-4PUB-08654625

Full text at the publisher3 results

Publisher page See results (3)

More studies

1 study on this page

Indexing hint: Clinical trial · 1996

Reduction of bone mineral density by gonadotropin-releasing hormone agonist, nafarelin, is not completely reversible at 6 months after the cessation of administration.

Taga et al. 1996Acta obstetricia et gynecologica Scandinavicacited by 18

PMID 8604604DOI 10.3109/00016349609033310PUB-08604604

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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