EndometriosisNCT04203212
BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH
An observational study of Endometriosis and Bone Density, run by 424 General Military Hospital at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Bone Density, Muscle
- What is being tested?
- Goserelin Acetate
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Premenopausal women with surgically verified endometriosis
Who cannot join
- Secondary osteoporosis
- diseases or conditions that could affect bone and/or muscle metabolism
- any medications that could affect bone and/or muscle metabolism
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Endometriosis, Bone Density, Muscle, Bone Metabolism
- Being tested
- Goserelin Acetate
- Keywords
- endometriosis, bone mineral density, myokines, sclerotin, periostin
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goserelin AcetateDrug
Also called GnRH analog
Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Goserelin Acetate | |
| Control Group | 20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumbar spine BMD
Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry
Measured: between baseline and 6 months after goserelin initiation
lumbar spine BMD
Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry
Measured: between baseline and 6 months after goserelin discontinuation
Secondary outcomes (9)
femoral neck BMD
Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry
Measured: between baseline and 6 months after goserelin initiation
femoral neck BMD
Bone mineral density changes at the femoral neck measured by dual-energy absorptiometry
Measured: between baseline and 6 months after goserelin discontinuation
sclerostin
bone metabolism parameter measured in sera
Measured: 0,6,12 months
periostin
bone metabolism parameter measured in sera
Measured: 0,3,6,12 months
irisin
myokine measured in sera
Measured: 0,3,6,12 months
follistatin
myokine measured in sera
Measured: 0,3,6,12 months
activin-A
myokine measured in sera
Measured: 0,3,6,12 months
noggin
BMP inhibitor measured in sera
Measured: 0,3,6,12 months
miRs
bone related microRNAs measured in sera
Measured: 0,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 251 Hellenic Air Force & VA General Hospital, Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Athanasios D. Anastasilakis, 424 General Military Hospital
- Investigators
- Athanasios Anastasilakis, PhD, Principal investigator, 424 General Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203212
- Sponsor's protocol ID
- Menomyobone
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After study results being accepted for publication they will be available for everyone that might ask for them
Publications
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.
PubMed 8654625Waibel-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.
PubMed 2526152Taga 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.
PubMed 8604604
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04203212
- Acronym / sponsor ID
- Menomyobone
- Conditions
- Endometriosis, Bone Density, Muscle, Bone Metabolism
- Keywords
- endometriosis, bone mineral density, myokines, sclerotin, periostin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Collaborators
- 251 Hellenic Air Force & VA General Hospital, Aristotle University Of Thessaloniki
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis Group | – | Drug: Goserelin Acetate20 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. |
| Control Group | – | –20 age- and BMI-matched premenopausal, health women who will receive no treatment and be monitored for 6 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Premenopausal women with surgically verified endometriosis
Key exclusion criteria (3 listed)
- Secondary osteoporosis
- diseases or conditions that could affect bone and/or muscle metabolism
- any medications that could affect bone and/or muscle metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goserelin AcetateAlso: GnRH analogGoserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months | Drug | Endometriosis Group |
Primary outcome
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
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
9 secondary outcomes
femoral neck BMD
Time frame: between baseline and 6 months after goserelin initiation
femoral neck BMD
Time frame: between baseline and 6 months after goserelin discontinuation
sclerostin
Time frame: 0,6,12 months
periostin
Time frame: 0,3,6,12 months
irisin
Time frame: 0,3,6,12 months
follistatin
Time frame: 0,3,6,12 months
activin-A
Time frame: 0,3,6,12 months
noggin
Time frame: 0,3,6,12 months
miRs
Time frame: 0,6,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 8654625Paoletti 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.
- Background: PubMed 2526152Waibel-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.
- Background: PubMed 8604604Taga 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.
- Individual participant dataSharing planned: Undecided. After study results being accepted for publication they will be available for everyone that might ask for them
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Anastasilakis, PhD principal investigator
424 General Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Bone Density, run by 424 General Military Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lumbar spine BMD (time frame: between baseline and 6 months after goserelin initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203212, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.