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临床试验/NCT06339489
NCT06339489招募中不适用

Explore the Bone Metabolism Characteristics of Premature Ovarian Insufficiency

Shi Yun1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
tartrate resistant acid phosphatase-5b, TRACP-5b

研究概览

简要总结

Explore the bone metabolism characteristics of premature ovarian insufficiency.

详细描述

Explore the bone metabolism characteristics of premature ovarian insufficiency, indexes includes serum levels of TRACP-5b and BALP, BMD values of lumbar spine L1-L4, left and right hip, left and right femoral neck et.al.

研究设计

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

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients diagnosed by Western medicine with premature ovarian insufficiency. 18 ≤ patients' age ≤ 39 years;. Patients who voluntarily participate in this study, sign an informed consent form.

排除标准

  • Patients with congenital gonadal dysplasia or a family history similar to "early menopause".
  • POI patients with acquired organic lesions or ovarian surgery. Patients who have taken Western or herbal medicine artificial cycle therapy or other endocrine therapy in the past three months.
  • Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system.
  • Patients who are breastfeeding or pregnant.

结局指标

主要结局

tartrate resistant acid phosphatase-5b, TRACP-5b

时间窗: On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled)

Blood samples are collected when enrolled.

次要结局

  • bone specific alkaline phosphatase, BALP(On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled))
  • bone mineral density, BMD(On the 2~4th day of menstruation (amenorrhea patients are collected when enrolled))

研究者

发起方
Shi Yun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shi Yun

Sponsor-Investigator

Dongzhimen Hospital, Beijing

研究点 (1)

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