Bony SclerosisSHSCLNCT01418924
Sex Hormones & Serum Sclerostin Level
An observational study of Bony Sclerosis and Testicular; Hormone, C, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine whether plasma sclerostin levels is affected by sex hormones during menstrual cycle. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bony Sclerosis, Testicular; Hormone, C
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2011to Oct 2011
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Premenopausal healthy women
Who may be able to join
- premenopausal women
- healthy
- volunteer
Who cannot join
- Endocrinopathies
- Bone disease (osteoporosis, osteomalacia, paget disease etc)
- Women who used hormonal drug within last six months
- Cognitive disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training & Research Hospital
Istanbul
About this study
Official title: Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle
The aim of this study is to determine whether plasma sclerostin levels is affected by sex hormones during menstrual cycle. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only one investigator
Read the detailed description
This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.
This study will be completed with 40 premenopausal healthy volunteer women. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle.
Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of plasma will be added to Ependorf tubes and stored at -20°C.
Plasma sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.
Estradiol and progesterone levels will be analyzed in serum samples using an electrochemiluminescence immunoassay (Elecsys PTH, Elecsys-estradiol II; Roche Diagnostics, Mannheim, Germany) and the Cobas 601 analyzing system (Roche Diagnostics).
Free testosteron levels will be analyzed in serum samples using an RIA (radio immun assay) (DSL 4900 Testosterone, Free, Active® RIA Assay kit, Beckman Coulter) and the DSL 4900 Berthold Technologies Multi Crystal LB 2111 model gama counter.
- Conditions
- Bony Sclerosis, Testicular; Hormone, C
- Keywords
- sclerostin, estradiol, progesterone, testosteron, sex hormones
- Medical subject headings
- Sclerosteosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sclerostin level
Changes in serum sclerostin level by sex hormons during menstrual cycle
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bony SclerosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Karacan, Bagcilar Training and Research Hospital
- Investigators
- MUHARREM CIDEM, MD, Principal investigator, Bagcilar Training & Research Hospital Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418924
- Sponsor's protocol ID
- BEAH FTR-4
- Acronym
- SHSCL
- Status last verified
- Oct 2011
- First submitted
- 16 Aug 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cidem M, Usta TA, Karacan I, Kucuk SH, Uludag M, Gun K. Effects of sex steroids on serum sclerostin levels during the menstrual cycle. Gynecol Obstet Invest. 2013;75(3):179-84. doi: 10.1159/000347013. Epub 2013 Feb 21.
PubMed 23429230
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle
- ClinicalTrials.gov ID
- NCT01418924
- Acronym / sponsor ID
- SHSCL / BEAH FTR-4
- Conditions
- Bony Sclerosis, Testicular; Hormone, C
- Keywords
- sclerostin, estradiol, progesterone, testosteron, sex hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Aug 2011 (estimated)
- 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 aim of this study is to determine whether plasma sclerostin levels is affected by sex hormones during menstrual cycle. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only one investigator
Detailed description
This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.
This study will be completed with 40 premenopausal healthy volunteer women. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained at the beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle.
Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of plasma will be added to Ependorf tubes and stored at -20°C.
Plasma sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.
Estradiol and progesterone levels will be analyzed in serum samples using an electrochemiluminescence immunoassay (Elecsys PTH, Elecsys-estradiol II; Roche Diagnostics, Mannheim, Germany) and the Cobas 601 analyzing system (Roche Diagnostics).
Free testosteron levels will be analyzed in serum samples using an RIA (radio immun assay) (DSL 4900 Testosterone, Free, Active® RIA Assay kit, Beckman Coulter) and the DSL 4900 Berthold Technologies Multi Crystal LB 2111 model gama counter.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Premenopausal healthy women
Key inclusion criteria (3 listed)
- premenopausal women
- healthy
- volunteer
Key exclusion criteria (4 listed)
- Endocrinopathies
- Bone disease (osteoporosis, osteomalacia, paget disease etc)
- Women who used hormonal drug within last six months
- Cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum sclerostin level
Time frame: 1 month
Changes in serum sclerostin level by sex hormons during menstrual cycle
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 20 Oct 2011.
- Derived from this study: PubMed 23429230Cidem M, Usta TA, Karacan I, Kucuk SH, Uludag M, Gun K. Effects of sex steroids on serum sclerostin levels during the menstrual cycle. Gynecol Obstet Invest. 2013;75(3):179-84. doi: 10.1159/000347013. Epub 2013 Feb 21.
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.
MUHARREM CIDEM, MD principal investigator
Bagcilar Training & Research Hospital Istanbul, Turkey
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 Bony Sclerosis and Testicular; Hormone, C, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 20 Oct 2011. 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 Turkey (Türkiye). 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?
Serum sclerostin level (time frame: 1 month). 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 NCT01418924, which also lists 1 linked publication.
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 20 Oct 2011.