Abstract

The objectives of the study are: To compare the response rate of patients receiving rIFN-ylb in conujunction with calcitriol to the response rate of patients receiving calcitriol alone. To determine the safety of rIFN-ylb administered to patients with osteopetrosis. To relate alterations in biologic response markers to disease outcome. The data to date has smaller numbers than the previous trials. There has been a trend towards an increase in bone turnover and cranial foraminal size. However, due to death and withdrawal for transplantations, the number of patients who have completed the trial is small. The most important accomplishment has been the recruitment of additional patients from Saudi Arabia (3) with the expectation to enroll 6-12 more. The enrollment rate of the US along with the Saudi Arabian enrollment should exceed the enrollment rate by the end of this year, and to move forward towards final approval.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001070-24
Application #
6308175
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
24
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Medical University of South Carolina
Department
Type
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29425

  Publications

Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 41:120-127
Putterman, Chaim; Pisetsky, David S; Petri, Michelle et al. (2018) The SLE-key test serological signature: new insights into the course of lupus. Rheumatology (Oxford) 57:1632-1640
Hall, Jordan T; Ebeling, Myla; Shary, Judy R et al. (2018) The relationship between physical activity and vitamin D status in postpartum lactating and formula-feeding women. J Steroid Biochem Mol Biol 177:261-265
Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Response to Comment on Kelly et al. Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 2018;41:120-127. Diabetes Care 41:e102-e103
Bell, Katherine A; Wagner, Carol L; Perng, Wei et al. (2018) Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr 196:168-174.e1
Sen, Sarbattama; Penfield-Cyr, Annie; Hollis, Bruce W et al. (2017) Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr 187:147-152.e1
Wolf, Bethany J; Spainhour, John C; Arthur, John M et al. (2016) Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol 68:1955-63
Wagner, C L; Baggerly, C; McDonnell, S et al. (2016) Post-hoc analysis of vitamin D status and reduced risk of preterm birth in two vitamin D pregnancy cohorts compared with South Carolina March of Dimes 2009-2011 rates. J Steroid Biochem Mol Biol 155:245-51
Hollis, Bruce W; Wagner, Carol L (2016) Response to commentary by D Roth. Evid Based Med 21:120
Hollis, Bruce W; Wagner, Carol L; Howard, Cynthia R et al. (2015) Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics 136:625-34

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