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Sponsor study identifier
Secondary identifiers
NIH
observational
484
1 country
2
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2019
Actual (reported)Study Completion
January 2019
Actual (reported)Compromised bone strength and increased fracture susceptibility pose significant morbidity and health care costs in children. Inadequate childhood bone accretion also may have lifelong consequences. Bone fragility among children with chronic medical conditions is a special concern. Identifying children at-risk for bone fragility and factors affecting bone strength requires understanding normal bone development. Dual energy x-ray absorptiometry (DXA) is the most common method for measuring bone mineral content and bone density in children. There are bone density reference data for children ages 5-20 years. An important gap is the lack of reference data for children ages \< 5 years, who also experience numerous medical conditions that threaten their bone health. Growth and body composition influence bone mineral accrual, and are important for interpreting bone density measurements in children with conditions that threaten bone health. Gross motor skills and subsequent physical activity may also affect bone accrual. Children with chronic illness are at risk of altered body composition, delayed growth and gross motor skills, and restricted physical activity. Understanding independent effects of growth, body composition, gross motor skills and physical activity on bone accrual will improve interpretation of bone density measurements and has important research and clinical applications for identifying risk factors and therapies for young children. This study will involve a longitudinal cohort of 280 children studied every 6 months for 3 years, and a cross-sectional cohort of 240 children measured once. The study will be conducted at 2 clinical centers \[Cincinnati Children's Hospital Medical Center (CCHMC) and the Children's Hospital of Philadelphia (CHOP)\] with equal enrollment at both centers. Measurements will include bone density, growth and body composition, dietary intake, sleep, physical activity and gross motor skills. Results from this study will enable clinical bone health assessment of young children with disorders that threaten bone health, and identify factors that affect bone accrual.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 11, 2014
Actual (reported)June 13, 2014
Actual (reported)January 2019
Actual (reported)January 2019
Actual (reported)Bone mineral density
Baseline
Bone mineral content
Baseline
Change in bone mineral density
Over 3 years
Change in bone mineral content
Over 3 years
Community sample
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Heidi Kalkwarf, PhD
Cincinnati Children's
Babette Zemel, PhD
Children's Hospital of Philadelphia
484 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2014
First Posted
June 13, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2019
Actual (reported)Study Completion
January 2019
Actual (reported)Last Updated
July 23, 2019
Record last verified: 2019-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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