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临床试验/NCT01418924
NCT01418924已完成不适用

Effects Of Sex Hormones On Serum Sclerostin Level During Menstrual Cycle

Bagcilar Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Serum sclerostin level

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • premenopausal women
  • volunteer

排除标准

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

结局指标

主要结局

Serum sclerostin level

时间窗: 1 month

Changes in serum sclerostin level by sex hormons during menstrual cycle

次要结局

未报告次要终点

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Karacan

Chief of Physical Med & Rehab Clinic

Bagcilar Training and Research Hospital

研究点 (1)

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