Bone Accrual and Hormones in Response to Lactation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning
研究概览
简要总结
This is a prospective observational trial of healthy postpartum women to investigate changes in bone density and markers of bone turnover during lactation. The study hypothesis is that women who breast-feed 5 months or more will lose bone density and subsequently regain the bone density after weaning. This study seeks to define determinants of the regain in bone density.
详细描述
This is a prospective observational trial enrolling healthy postpartum women, ages 20 years and older with the intent to breast-feed from the UNC outpatient obstetrical clinics and the UVA outpatient obstetrical clinics. These women were studied at 3-5 visits in the year following their delivery to assess bone density, nutritional intake, exercise, and breast-feeding choices. The number of study visits depended on the timing of return of menses and interest in participating in the follow-up study (timepoints are: immediate postpartum, 3 months postpartum, return of menses, 6 months after return of menses and follow-up visit 6 months after final visit). Blood was taken for analysis of bone-related hormones, bone turnover and calcium homeostasis markers. The study focuses on women with extended lactation (at least 5 months of lactation) whereas women who cease lactation prior to 3 months will be the primary comparison group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age >20 at the time of delivery
- •singleton pregnancy and
- •<2 prior pregnancies that were >20 weeks gestation.
- •Exclusion criteria:
- •maternal rheumatologic disorders
- •maternal anorexia nervosa
- •maternal endocrinologic disorders,
- •medications known to affect bone density such as corticosteroids, thyroid hormone use, anticonvulsant therapy, bisphosphonates, long-term GnRH agonists use and calcitonin.
- •Subsequent pregnancy during the study
排除标准
- 未提供
结局指标
主要结局
The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning
时间窗: ~Two Years
次要结局
- The association of changes in bone density and change in bone turnover markers during lactation and weaning.(~Two years)
研究者
Sue Brown
Assistant Professor of Medicine
University of Virginia