Sex Hormones & Serum Sclerostin Level | NCT01418924

Studies
Sex Hormones & Serum Sclerostin Level

NCT01418924

Sponsor

Bagcilar Training and Research Hospital

Status

Completed

Last Update Posted

Oct 20, 2011Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Bony Sclerosis
Testicular; Hormone, C

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Aug 16, 2011

First Submission Date that Met QC Criteria

Aug 16, 2011

First Posted Date

Aug 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2011

Last Update Posted Date

Oct 20, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Bagcilar Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum sclerostin level	Changes in serum sclerostin level by sex hormons during menstrual cycle	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Premenopausal healthy women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MUHARREM CIDEM, MD	Bagcilar Training & Research Hospital Istanbul, Turkey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bagcilar Training & Research Hospital		Istanbul			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23429230	Derived	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.