Multiparametric evaluation of bone health in women with premature ovarian insufficiency: A prospective cross-sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- BMD at the spine and hip, TBS, serum levels of Osteopontin, P1NP, Beta Cross Laps
研究概览
简要总结
Primary ovarian insufficiency (POI) is the cessation of ovarian function before the expected age of menopause and is defined by oligo/amenorrhea for at least 4 months, and an elevated FSH level more than 25 IU/l on two occasions at least 4 weeks apart in women under the age of 40 years. POI has long term consequences. It affects bone health and leads to osteoporosis. Hence early detection is important to initiate treatment before POI affects the bone health.
Primary objective of this study is to evaluate bone health in women with POI as assessed by multiple parameters of bone health including bone mineral density (BMD), Trabecular bone score (TBS) and serum biomarkers.
Secondary objective of this study is to compare BMD, TBS and serum levels of P1NP, Osteopontin, Beta Cross Laps in women with POI with controls and to assess awareness of women for impact of POI on their bone health.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects Women with POI meeting all the following criteria.
- •Age less than 40 years.
- •Secondary amenorrhea for at least four months.
- •Elevated FSH 25.0 IU/L on two occasions at least 4 weeks apart Controls.
- •Age and parity matched healthy women with normal menstrual cycles and serum FSH in normal range.
排除标准
- •Both subjects and controls.
- •History of surgery on tubes/ovaries, post radiation, post chemotherapy.
- •Any systemic illness, History of chronic renal disease.
- •Hyperthyroidism, hyperparathyroidism.
- •On corticosteroids and anticonvulsant therapy which are known to affect bone metabolism.
- •Unwilling to give written informed consent.
结局指标
主要结局
BMD at the spine and hip, TBS, serum levels of Osteopontin, P1NP, Beta Cross Laps
时间窗: At baseline
次要结局
- - Number of women with POI who have bone density scores less than one standard deviation below the mean of the reference group in spine and/or hip region(- Correlation of biomarkers levels with BMD & TBS)
研究者
Vidushi Kulshrestha
AIIMS New Delhi