A Prospective Observational Study of Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 54
- 主要终点
- Percentage change in BMD in the femoral neck and total hip.
研究概览
简要总结
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
详细描述
This is a prospective observational study to characterize longitudinal BMD of premenopausal women with uterine fibroids or endometriosis over the 52-week observational period.
Approximately 660 participants will be recruited into two cohorts: (1) premenopausal women with uterine fibroids confirmed by an ultrasound (approximately 260 participants), and (2) premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit (approximately 400 participants).
Since age is a strong risk factor for BMD change over time, participants in this observational study will be matched by age category (18 to 24, 25 to 34, 35 to 44, and ≥45 years old), with participants enrolled in the interventional studies of relugolix.
During the Screening/Baseline period, the participant should be assessed for eligibility, and baseline dual-energy X-ray absorptiometry (DXA) scan will be obtained. Bone densitometry (lumbar spine [L1-L4], total hip, and femoral neck) will be obtained and submitted for central reading at Baseline, Week 24, and Week 52.
Information related to health care utilization for uterine fibroids or endometriosis and concomitant medications will be collected at every visit and during the phone calls at Week 12 and Week 36.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is a premenopausal female 18 to 50 years old
- •By the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. Participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles.
- •Has one of the following conditions:
- •Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
- •Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.
- •Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.
排除标准
- •Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
- •Has a baseline BMD z-score < -2.0 at spine, total hip, or femoral neck
- •Has a history of or currently has osteoporosis, or other metabolic bone disease
- •Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
- •Is currently pregnant or lactating, or intends to become pregnant during the study period
结局指标
主要结局
Percentage change in BMD in the femoral neck and total hip.
时间窗: from Baseline up to Week 52
Assessed by DXA scan.
Absolute change in BMD in the lumbar spine (L1-L4), femoral neck and total hip.
时间窗: from Baseline up to Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Percentage change in Bone Mineral Density (BMD) in lumbar spine (L1-L4).
时间窗: from Baseline up to Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
次要结局
- Healthcare utilization for uterine fibroids or endometriosis(over 52 weeks)
- Frequency of concomitant medication use.(over 52 weeks)
- Change from Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L).(from Baseline up to Week 52)