SHSCL: Sex Hormones & Serum Sclerostin Level

Sponsor

Bagcilar Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01418924

Collaborator

(none)

Enrollment

Location

Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. Serum sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only one investigator

Condition or Disease	Intervention/Treatment	Phase
Bony Sclerosis Testicular; Hormone, C

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

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

Serum sclerostin level [1 month]
Changes in serum sclerostin level by sex hormons during menstrual cycle

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bagcilar Training & Research Hospital	İstanbul		Turkey

Sponsors and Collaborators

Bagcilar Training and Research Hospital

Investigators

Principal Investigator: MUHARREM CIDEM, MD, Bagcilar Training & Research Hospital Istanbul, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karacan, Chief of Physical Med & Rehab Clinic, Bagcilar Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT01418924

Other Study ID Numbers:

BEAH FTR-4

First Posted:

Aug 17, 2011

Last Update Posted:

Oct 20, 2011

Last Verified:

Oct 1, 2011

Keywords provided by Karacan, Chief of Physical Med & Rehab Clinic, Bagcilar Training and Research Hospital

Study Results

No Results Posted as of Oct 20, 2011