Markers of Osteoporosis in Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- DEXA results
研究概览
简要总结
Main Study Up to 100 subjects, both non-CF volunteers and Cystic Fibrosis (CF) patients, will participate in a single study visit that will include a DEXA scan, micro CT, and blood collection.
Denosumab (Prolia) Sub study Approximately 10 adult subjects with CF who participated in the main study and have results indicating bone disease will receive treatment with Denosumab for up to 5 years. They will be asked to return annually for repeat DEXA scans, micro CT, and blood collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have CF diagnosis confirmed by sweat test or genotype analysis
- •Subjects (and parents/legal guardians as applicable) must have the ability to read and write in English
排除标准
- •No CF diagnosis
- •Men or women without osteoporosis
- •Less than 18 years of age
- •Unwilling to return annually for study visits for up to 5 years
- •Unwilling and/or medically unable to take denosumab
研究组 & 干预措施
Denosomab Sub-study
Approximately 10 subjects with CF that have completed the main study and have results which indicate bone disease are eligible to participate in the sub study. Subjects who consent will receive treatment with denosumab (60 mg/ml via subcutaneous injection in the upper arm, upper thigh, or abdomen every 6 months) for up to 5 years. These subjects will be asked to return every 6 months for injections and annually (+/- 6 months) for up to 5 years for a DEXA scan, micro CT, and blood collection.
干预措施: Denosumab (Drug)
结局指标
主要结局
DEXA results
时间窗: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
Z and/or T scores
Micro CT results
时间窗: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
Trabecular bone volume to tissue volume (BV/TV), cortical and trabecular thickness (Tb.Th, microns), trabecular spacing (Tb.Sp; microns), and structure model index (SMI; index of trabecular rod vs plate-like shape/ stoutness) will be assessed. Change in BV/TV and cortical thickness will be taken to indicate increased/decreased bone mass accrual by microCT.
次要结局
未报告次要终点
研究者
Raksha Jain
Associate Professor of Medicine
University of Texas Southwestern Medical Center