This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This study compares the safety and effectiveness of two medications in children with severe osteogenesis imperfecta. Children between 1 and 17 years of age who have types III and IV osteogenesis, or who have type I osteogenesis with a history of 3 or more minimal trauma fractures in the past two years or a history of limb deformity requiring surgery are eligible. One of the medications, pamidronate, has already been shown to reduce fractures in osteogenesis imperfecta. Aledronate is a new drug of the same type as pamidronate, but it is more powerful and may be a good alternative if it is effective and safe. This study is the first time zoledronate is being used in children with osteogenesis imperfecta. This study lasts for 13 months and includes 10-15 visits. Children are treated with one of the study drugs at either 2 month or 3 month intervals during that year. Physical exams, blood and urine studies, x-rays and bone density measurements are made throughout the study. In addition to the study medication, children take multivitamins and calcium supplements. This is an international, multi-center study, and 136 children will be treated, study-wide. Half of the children will receive treatment with pamidronate and half will receive treatment with zoledronate. Some children who receive zoledronate will have additional lab work to study the pharmacokinetics (processing by the body) of this drug in children.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR008084-14
Application #
7607748
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-02-15
Project End
2007-11-30
Budget Start
2007-02-15
Budget End
2007-11-30
Support Year
14
Fiscal Year
2007
Total Cost
$3,343
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Jilling, Tamas; Ambalavanan, Namasivayam; Cotten, C Michael et al. (2018) Surgical necrotizing enterocolitis in extremely premature neonates is associated with genetic variations in an intergenic region of chromosome 8. Pediatr Res 83:943-953
Natarajan, Girija; Shankaran, Seetha; Laptook, Abbot R et al. (2018) Association between sedation-analgesia and neurodevelopment outcomes in neonatal hypoxic-ischemic encephalopathy. J Perinatol 38:1060-1067
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
DiFrancesco, Mark W; Shamsuzzaman, Abu; McConnell, Keith B et al. (2018) Age-related changes in baroreflex sensitivity and cardiac autonomic tone in children mirrored by regional brain gray matter volume trajectories. Pediatr Res 83:498-505
Autmizguine, Julie; Tan, Sylvia; Cohen-Wolkowiez, Michael et al. (2018) Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis. Pediatr Infect Dis J 37:923-929
Zeller, Meg H; Pendery, Emma C; Reiter-Purtill, Jennifer et al. (2017) From adolescence to young adulthood: trajectories of psychosocial health following Roux-en-Y gastric bypass. Surg Obes Relat Dis 13:1196-1203
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Shankaran, Seetha; Laptook, Abbot R; McDonald, Scott A et al. (2017) Acute Perinatal Sentinel Events, Neonatal Brain Injury Pattern, and Outcome of Infants Undergoing a Trial of Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy. J Pediatr 180:275-278.e2
Hogan, Jonathan J; Palmer, Matthew D; Loren, Alison W et al. (2017) Quiz Page May 2017: CKD and Nephrotic Syndrome After Allogeneic Hematopoietic Cell Transplantation. Am J Kidney Dis 69:A10-A13
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1

Showing the most recent 10 out of 502 publications