Sex Hormones & Serum Sclerostin Level (SHSCL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karacan, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01418924
First received: August 16, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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
Bony Sclerosis
Testicular; Hormone, C

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Serum sclerostin level [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Changes in serum sclerostin level by sex hormons during menstrual cycle


Enrollment: 45
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Premenopausal healthy women

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418924

Locations
Turkey
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
  More Information

No publications provided by Bagcilar Training and Research Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karacan, Chief of Physical Med & Rehab Clinic, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01418924     History of Changes
Other Study ID Numbers: BEAH FTR-4
Study First Received: August 16, 2011
Last Updated: October 19, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Bagcilar Training and Research Hospital:
sclerostin
estradiol
progesterone
testosteron
sex hormones

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014