Bone Mineral Density in Childhood Study Data Coordinating Center

儿童骨矿物质密度研究数据协调中心

• 批准号: 8549559
• 负责人: NA NA
• 金额: $ 1万
• 依托单位: CLINICAL TRIALS AND SURVEYS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-05-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8549559
• 关键词: Age; Asthma; Bone Density; Breathing; Calibration; Child; Childhood; Chronic Disease; Clinical; DEXA; Data; Data Collection; Data Coordinating Center; Databases; Endocrinologist; Evaluation; Gender; Growth; Height; Individual; Investigation; Measurement; Measures; Minority; Nurse Practitioners; Oral; Pharmaceutical Preparations; Phase; Pilot Projects; Procedures; Protocols documentation; Puberty; Radiology Specialty; Reading; Recruitment Activity; Scanning; Site; Steroid therapy; Subjects Selections; Supervision; Testing; Time; Training; Visit; Weight; age group; base; bone age; follow-up; instrument; meetings; radiologist; research clinical testing; skeletal

To conduct a multicenter longitudinal investigation of normative bone density, skeletal, and pubertal maturation data in children. Normative growth and bone density measurements will be obtained annually for three consecutive years. The children will undergo a yearly radiographic evaluation including DEXA and bone age x-ray and also an evaluation by a pediatric endocrinologist or nurse practitioner to determine pubertal status, height, weight, and BM!. Heights will be taken on a calibrated stadiometer and measured in triplicate to assure accuracy. Each clinical center will enter the growth and puberty data that they generate and transmit these data electronically to the data coordinating center. All of the radiology data (bone age and bone density studies) will be read centrally by a radiologist appointed by the data- coordinating center. Those data will be entered directly into the centralized database located at the coordinating center. On a monthly basis, the clinical centers will arrange for the supervision of the calibration of their bone density instruments. The clinical centers will conduct a pilot study on a total of 12 children to test the study procedures and instruments.

对儿童正常骨密度、骨骼和青春期成熟数据进行多中心纵向研究。将连续三年每年获得正常生长和骨密度测量结果。儿童将接受每年一次的影像学评价，包括DEXA和骨龄X线检查，以及儿科内分泌学家或执业护士的评价，以确定青春期状态、身高、体重和BM！。将在经校准的测距仪上测量高度，并重复测量三次，以确保准确性。各临床中心将输入其生成的生长和青春期数据，并以电子方式将这些数据传输至数据协调中心。所有放射学数据（骨龄和骨密度研究）将由数据协调中心指定的放射科医生集中读取。这些数据将直接输入设在协调中心的中央数据库。临床中心会每月安排监督校正其骨密度仪器。临床中心将对总共12名儿童进行试点研究，以测试研究程序和仪器。