Sex Hormones & Serum Sclerostin Level

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

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Key information

Conditions

Bony Sclerosis Sclerosteosis Testicular; Hormone, C

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

Serum sclerostin level

Time frame: 1 month

Changes in serum sclerostin level by sex hormons during menstrual cycle

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle

Acronym: SHSCL

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Aug 17, 2011
Registry last updated: Oct 20, 2011

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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Completed