Sex Hormones & Serum Sclerostin Level

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

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Bony Sclerosis Testicular; Hormone, C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* premenopausal women
* healthy
* volunteer

Exclusion Criteria

* Endocrinopathies
* Bone disease (osteoporosis, osteomalacia, paget disease etc)
* Women who used hormonal drug within last six months
* Cognitive disorders

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Karacan

Chief of Physical Med & Rehab Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MUHARREM CIDEM, MD

Role: PRINCIPAL_INVESTIGATOR

Bagcilar Training & Research Hospital Istanbul, Turkey

Locations

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Bagcilar Training & Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED

PMID: 23429230 (View on PubMed)

Other Identifiers

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BEAH FTR-4

Identifier Type: -

Identifier Source: org_study_id