Bone Mineral Density in Childhood Study Data Coordination Center

儿童骨矿物质密度研究数据协调中心

• 批准号: 8549555
• 金额: $ 1.54万
• 依托单位: CLINICAL TRIALS AND SURVEYS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-12-20 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8549555
• 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.

对儿童的正常骨密度、骨骼和青春期成熟数据进行多中心纵向调查。连续三年每年进行一次正常生长和骨密度测量。孩子们将每年接受一次放射学评估，包括 DEXA 和骨龄 X 光检查，并由儿科内分泌科医生或执业护士进行评估，以确定青春期状态、身高、体重和 BM！高度将在校准的测高仪上进行测量，并进行三次测量以确保准确性。每个临床中心将输入他们生成的生长和青春期数据，并将这些数据以电子方式传输到数据协调中心。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位于协调中心的中央数据库中。临床中心每月都会安排对其骨密度仪器的校准进行监督。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。